Ultragen Ltd · 89-08 · ISRAEL
For Ultragen Ltd, import alert is 89-08; country is ISRAEL; 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 is Tripollar POSE; Tripollar STOP; product code is 89 H - - PH Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat; date published is 08/02/2011; address is 6 Kaufman Street , Gabor House, Po Box 50320 , Tel Aviv, ISRAEL, verified against its source on 2026-09-30.
- Firm
- Ultragen 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
- ISRAEL verified
- Address
- 6 Kaufman Street , Gabor House, Po Box 50320 , Tel Aviv, ISRAEL verified
- Date published
- 08/02/2011 verified
- Product code
- 89 H - - PH Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat verified
- Product
- Tripollar POSE; Tripollar STOP verified
- FDA notes
- Class II verified
What the source says
Ultragen Ltd Date Published : 08/02/2011 6 Kaufman Street , Gabor House, Po Box 50320 , Tel Aviv, ISRAEL
— 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, Product and FDA notes
89 H - - PH Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat Date Published: 08/02/2011 Desc: Tripollar POSE; Tripollar STOP Notes: Class II
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html