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Implant & Instrument Sterilization Tray
FDA UDIClass I (US FDA UDI)
by Biopro, Inc.
Identity
- Trade Name
- IMPLANT & INSTRUMENT STERILIZATION TRAY FDA UDI
- Generic Name
- Self-retaining surgical retractor, single-use FDA UDI
- Model / Reference
- 21706 FDA UDI
Identifiers
- Primary DI / UDI-DI
- M209217060 FDA UDI
- 510(k) Number
- K163627 FDA UDI
- FDA Product Code
- HWN FDA UDI
- GMDN Term
- Self-retaining surgical retractor, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Self-retaining surgical retractor, single-use
Implant & Instrument Sterilization Tray by Biopro, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Self-retaining surgical retractor, single-use.
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- Endo Mini-Retract — Covidien LP · Class II
- Sklar® — Sklar Corporation · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- Endo Retract — Covidien LP · Class I
Cleared under the same submission
K163627 also covers:
- 10MM NAIL CAP — BIOPRO, INC.
- 10MM NAIL CAP — BIOPRO, INC.
- 11MM FUSION NAIL, RIGHT — BIOPRO, INC.
- 11MM FUSION NAIL, RIGHT — BIOPRO, INC.
- 11MM NAIL CAP + 5MM — BIOPRO, INC.
- 11MM NAIL CAP + 5MM — BIOPRO, INC.
- 12MM FUSION NAIL, RIGHT — BIOPRO, INC.
- 12MM NAIL CAP + 5MM — BIOPRO, INC.
- 13MM FUSION NAIL, RIGHT — BIOPRO, INC.
- 13MM NAIL CAP — BIOPRO, INC.
- 14MM FUSION NAIL, RIGHT — BIOPRO, INC.
- 15MM FUSION NAIL, LEFT — BIOPRO, INC.
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
- Biopro, Inc.
Sources (1)
- FDA UDI 45281426-75c3-4541-99f0-13b4974e8e7e 33 fields · synced Jun 1, 2026