GAELTEC DEVICES LTD · 89-08 · UNITED KINGDOM
For GAELTEC DEVICES LTD, import alert is 89-08; country is UNITED KINGDOM; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; product code is 73 - - - -- Anesthesiology | 74 - - - -- Cardiovascular | 76 - - - -- Dental | 77 - - - -- Ear,Nose And Throat | 78 - - - -- Gastroenterological & Urological | 79 - - - -- General & Plastic Surgery | 80 - - - -- General Hospital/Personal Use | 84 - - - -- Neurological | 85 - - - -- Obstetrical & Gynecological | 86 - - - -- Ophthalmic | 87 - - - -- Orthopedic | 89 - - - -- Physical Medicine | 90 - - - -- Radiology; date published is 08/14/2018; address is Dunvegan Fire Station , Glendale Road , Isle Of Skye, HLD UNITED KINGDOM, verified against its source on 2026-09-30.
- Firm
- GAELTEC DEVICES LTD verified
- Import alert
- 89-08
- Import alert name
- "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- Country
- UNITED KINGDOM verified
- Address
- Dunvegan Fire Station , Glendale Road , Isle Of Skye, HLD UNITED KINGDOM verified
- Date published
- 08/14/2018 verified
- Product code
- 73 - - - -- Anesthesiology | 74 - - - -- Cardiovascular | 76 - - - -- Dental | 77 - - - -- Ear,Nose And Throat | 78 - - - -- Gastroenterological & Urological | 79 - - - -- General & Plastic Surgery | 80 - - - -- General Hospital/Personal Use | 84 - - - -- Neurological | 85 - - - -- Obstetrical & Gynecological | 86 - - - -- Ophthalmic | 87 - - - -- Orthopedic | 89 - - - -- Physical Medicine | 90 - - - -- Radiology each item verified
- FDA notes
- All medical devices | All medical devices | All medical devices | All medical devices | All medical devices | All medical devices | All medical devices | All medical devices | All medical devices | All medical devices | All medical devices | All medical devices | All medical devices each item verified
What the source says
GAELTEC DEVICES LTD Date Published : 08/14/2018 Dunvegan Fire Station , Glendale Road , Isle Of Skye, HLD UNITED KINGDOM
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code and FDA notes
73 - - - -- Anesthesiology Date Published: 08/14/2018 Notes: All medical devices 74 - - - -- Cardiovascular Date Published: 08/14/2018 Notes: All medical devices 76 - - - -- Dental Date Published: 08/14/2018 Notes: All medical devices 77 - - - -- Ear,Nose And Throat Date Published: 08/14/2018 Notes: All medical devices 78 - - - -- Gastroenterological & Urological Date Published: 08/14/2018 Notes: All medical devices 79 - - - -- General & Plastic Surgery Date Published: 08/14/2018 Notes: All medical devices 80 - - - -- General Hospital/Personal Use Date Published: 08/14/2018 Notes: All medical devices 84 - - - -- Neurological Date Published: 08/14/2018 Notes: All medical devices 85 - - - -- Obstetrical & Gynecological Date Published: 08/14/2018 Notes: All medical devices 86 - - - -- Ophthalmic Date Published: 08/14/2018 Notes: All medical devices 87 - - - -- Orthopedic Date Published: 08/14/2018 Notes: All medical devices 89 - - - -- Physical Medicine Date Published: 08/14/2018 Notes: All medical devices 90 - - - -- Radiology Date Published: 08/14/2018 Notes: All medical devices
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html