Identity
- Trade Name
- Ambler Surgical FDA UDI
- Generic Name
- Upper-limb traction wrap/trap, reusable FDA UDI
- Device Name
- Bookwalter-Style lateral vaginal retractor, 1'' x 3'' blade FDA UDI
- Model / Reference
- Bookwalter-Style lateral vaginal retractor FDA UDI
- Description
- Bookwalter-Style lateral vaginal retractor, 1'' x 3'' blade FDA UDI
Identifiers
- Catalog Number
- 70-669 FDA UDI
- Primary DI / UDI-DI
- 00190660213985 FDA UDI
- 510(k) Number
- K071771 FDA UDI
- FDA Product Code
- GZT FDA UDI
- GMDN Term
- Upper-limb traction wrap/trap, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Upper-limb traction wrap/trap, reusable
Ambler Surgical by Ambler Surgical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Upper-limb traction wrap/trap, reusable.
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Cleared under the same submission
K071771 also covers:
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ambler Surgical, LLC
Sources (1)
- FDA UDI a1a6be0c-fe46-4403-8f00-57075f3f3f4c 36 fields · synced May 31, 2026