Identity
- Trade Name
- Ambler Surgical FDA UDI
- Generic Name
- Surgical retractor/retraction system blade, reusable FDA UDI
- Device Name
- Henly retractor, 6 1/2'', interchangeable blades, complete set includes 3 pairs of side blades 1'' x 7/8'' wide, 2'' x 7/8'' wide and 3'' x 7/8'' wide, with 4 blunt prongs, also 3 center blades 3/4'' x 5/8'' wide, 1'' x 5/8'' wide and 1 1/4'' x 5/8'' wide, ring handle with ratchet catch (71-890, 71-891, 71-892, 71-850, 71-851, 71-852 and 71-855) FDA UDI
- Model / Reference
- Henly retractor FDA UDI
- Description
- Henly retractor, 6 1/2'', interchangeable blades, complete set includes 3 pairs of side blades 1'' x 7/8'' wide, 2'' x 7/8'' wide and 3'' x 7/8'' wide, with 4 blunt prongs, also 3 center blades 3/4'' x 5/8'' wide, 1'' x 5/8'' wide and 1 1/4'' x 5/8'' wide, ring handle with ratchet catch (71-890, 71-891, 71-892, 71-850, 71-851, 71-852 and 71-855) FDA UDI
Identifiers
- Catalog Number
- 71-895 FDA UDI
- Primary DI / UDI-DI
- 00190660136611 FDA UDI
- FDA Product Code
- FFO FDA UDI
- GMDN Term
- Surgical retractor/retraction system blade, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.4730 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
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: Surgical retractor/retraction system blade, reusable
Ambler Surgical by Ambler Surgical, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Ambler Surgical, LLC
Sources (1)
- FDA UDI 3fd5a56d-3120-455f-bd0f-90a30d0031d1 35 fields · synced Jun 1, 2026