Industrias Manufactureras De Tamaulipas S.A. de C.V. · 89-08 · MEXICO
For Industrias Manufactureras De Tamaulipas S.A. de C.V. · 89-08 · MEXICO, import alert is 89-08; 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)"; country is MEXICO; product is Thermofleet Blanket | Thermofleet Blanket; product code is 79 E - - RY Drape, Surgical, Ent | 80 K - - ME Bedding, Disposable, Medical; date published is 01/22/2010; address is Calle Ignacio Zaragoza # 203 , Col. CHINA , China, Nuevo Leon MEXICO, verified against its source on 2026-09-16.
- Firm
- Industrias Manufactureras De Tamaulipas S.A. de C.V. 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
- MEXICO verified
- Address
- Calle Ignacio Zaragoza # 203 , Col. CHINA , China, Nuevo Leon MEXICO verified
- Date published
- 01/22/2010 verified
- Product code
- 79 E - - RY Drape, Surgical, Ent | 80 K - - ME Bedding, Disposable, Medical each item verified
- Product
- Thermofleet Blanket | Thermofleet Blanket each item verified
- FDA notes
- Class II Please examine labeling for MRI use/compatibility/¿MR conditional". If the product does not contain the MRI labeling, please release the product. However if it does, please do not release the product pending guidance from DIOP or CDRH. | Class I Please examine labeling for MRI use/compatibility/¿MR conditional". If the product does not contain the MRI labeling, please release the product. However if it does, please do not release the product pending guidance from DIOP or CDRH. each item verified
What the source says
Industrias Manufactureras De Tamaulipas S.A. de C.V. Date Published : 01/22/2010 Calle Ignacio Zaragoza # 203 , Col. CHINA , China, Nuevo Leon MEXICO 79 E - - RY Drape, Surgical, Ent Date Published: 01/22/2010 Desc: Thermofleet Blanket Notes: Class II Please examine labeling for MRI use/compatibility/¿MR conditional". If the product does not contain the MRI labeling, please release the product. However if it does, please do not release the product pending guidance from DIOP or CDRH. 80 K - - ME Bedding, Disposable, Medical Date Published: 01/22/2010 Desc: Thermofleet Blanket Notes: Class I Please examine labeling for MRI use/compatibility/¿MR conditional". If the product does not contain the MRI labeling, please release the product. However if it does, please do not release the product pending guidance from DIOP or CDRH.
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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