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Gimbel Stabilization Ring, Offset 13mm with 9mm opening, Blunt Teeth On Both Sid
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Gimbel Stabilization Ring, Offset 13mm with 9mm opening, Blunt Teeth On Both Sid FDA UDI
- Generic Name
- Eyeball fixation instrument, reusable FDA UDI
- Device Name
- Gimbel Stabilization Ring, Offset 13mm with 9mm opening, Blunt Teeth On Both Sides Of Swivel FDA UDI
- Model / Reference
- AS1-352T FDA UDI
- Description
- Gimbel Stabilization Ring, Offset 13mm with 9mm opening, Blunt Teeth On Both Sides Of Swivel FDA UDI
Identifiers
- Catalog Number
- AS1-352T FDA UDI
- Primary DI / UDI-DI
- 08175700105552 FDA UDI
- FDA Product Code
- HNH FDA UDI
- GMDN Term
- Eyeball fixation instrument, reusable 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
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: Eyeball fixation instrument, reusable
Gimbel Stabilization Ring, Offset 13mm with 9mm opening, Blunt Teeth On Both Sid by Aurora Surgical, Llc — Class I — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Eyeball fixation instrument, reusable.
- Flieringa Scleral Fixation Ring, 13mm — KATALYST SURGICAL, LLC · Class I
- Walcott Rx Products — Walcott Rx Product Inc · Class I
- Wexler Surgical, Inc. — Wexler Surgical, Inc. · Class I
- Rumex — Rumex International Co. · Class I
- FINE-THORNTON FIXATION RING 13MM — Katena Products, Inc. · Class I
- Flieringa Scleral Fixation Ring, 24mm — KATALYST SURGICAL, LLC · Class I
- TWIST HOOK RIGHT — Katena Products, Inc. · Class I
- Flieringa Scleral Fixation Ring, 9mm — KATALYST SURGICAL, LLC · 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 |
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Manufacturer
- Manufacturer
- Aurora Surgical, Llc
Sources (1)
- FDA UDI 897737f8-f4e2-45ea-966d-e35a076fadd2 34 fields · synced May 30, 2026