Identity
- Trade Name
- Ambler Surgical FDA UDI
- Generic Name
- Ophthalmic knife, single-use FDA UDI
- Device Name
- 15 degree stab blade, straight NexGen blade, screw-in collet, round stock, packaged individually, sterile, disposable, box of 6 FDA UDI
- Model / Reference
- 15 degree stab blade FDA UDI
- Description
- 15 degree stab blade, straight NexGen blade, screw-in collet, round stock, packaged individually, sterile, disposable, box of 6 FDA UDI
Identifiers
- Catalog Number
- 961502 FDA UDI
- Primary DI / UDI-DI
- 10190660200005 FDA UDI
- FDA Product Code
- HNN FDA UDI
- GMDN Term
- Ophthalmic knife, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4350 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ophthalmic knife, single-use
Ambler Surgical by Ambler Surgical, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic knife, single-use.
- MANI Ophthalmic Knife — MANI, INC. · Class I
- Ophthalmic Knife — Katena Products, Inc. · Class I
- MANI Ophthalmic Knife — MANI, INC. · Class I
- MANI Ophthalmic Knife — MANI, INC. · Class I
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- MANI Ophthalmic Knife — MANI, INC. · Class I
- Anodyne Surgical — Psi/Eye-Ko, Inc. · Class I
- MANI Ophthalmic Knife — MANI, INC. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ambler Surgical, LLC
Sources (1)
- FDA UDI 0aa0d97a-459e-403f-b669-5b05b80dee2b 35 fields · synced Jun 7, 2026