Identity
- Trade Name
- GEN2 FDA UDI
- Generic Name
- Manual orthopaedic bender, single-use FDA UDI
- Device Name
- ROD BENDER, 11'' FDA UDI
- Model / Reference
- G2N82010 FDA UDI
- Description
- ROD BENDER, 11'' FDA UDI
Identifiers
- Catalog Number
- G2N82010 FDA UDI
- Primary DI / UDI-DI
- 00840343719265 FDA UDI
- FDA Product Code
- HXP FDA UDI
- GMDN Term
- Manual orthopaedic bender, 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
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
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
Dimensions & Sizes
- Size
- Length — 11 Inch FDA UDI
Category: Manual orthopaedic bender, single-use
Gen2 by Surgix Medical Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Manual orthopaedic bender, single-use.
- Plate Benders (M) (2 Pieces) — FLOWER ORTHOPEDICS CORPORATION · Class I
- ZERO-P NATURAL — Synthes · Class II
- Plate Benders (S) (2 Pieces) — FLOWER ORTHOPEDICS CORPORATION · Class I
- EPS Plating System — GRAMERCY EXTREMITY ORTHOPEDICS, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Surgix Medical Llc
Sources (1)
- FDA UDI 54fcd523-267b-4a3e-8d50-58c0497a039a 36 fields · synced May 29, 2026