Identity
- Trade Name
- OIC Suture Anchor System FDA UDI
- Generic Name
- Operative-site suture holder FDA UDI
- Device Name
- SUTURE THREADER FDA UDI
- Model / Reference
- 01-SA03 FDA UDI
- Description
- SUTURE THREADER FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10811998038787 FDA UDI
- 510(k) Number
- K182736 FDA UDI
- FDA Product Code
- MBI FDA UDI
- GMDN Term
- Operative-site suture holder FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Operative-site suture holder
OIC Suture Anchor System by Orthopaedic Implant Company, The — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Operative-site suture holder.
- Wexler Surgical, Inc. — Wexler Surgical, Inc. · Class I
- Surge Cardiovascular — MED MICHIGAN HOLDINGS LLC · Class I
- HEART XS — AESCULAP, INC. · Class I
- ExpressBraid™ Graft Manipulation — Biomet Orthopedics, Inc. · Class II
- ExpressBraid™ Graft Manipulation — Biomet Orthopedics, Inc. · Class II
- EXPRESSBRAID GRAFT MANIPULATION — Biomet Orthopedics, Inc. · Class II
- MicroSurge — MED MICHIGAN HOLDINGS LLC · Class I
- DELACROIX-CHEVALIER — LANDANGER · Class I
Cleared under the same submission
K182736 also covers:
- OIC Suture Anchor System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Suture Anchor System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Suture Anchor System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Suture Anchor System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Suture Anchor System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Suture Anchor System — ORTHOPAEDIC IMPLANT COMPANY, THE
- OIC Suture Anchor System — ORTHOPAEDIC IMPLANT COMPANY, THE
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Orthopaedic Implant Company, The
Sources (1)
- FDA UDI 919ff747-d02d-4c52-a936-33a912f0a327 35 fields · synced May 30, 2026