Identity
- Trade Name
- ACE FDA UDI
- Generic Name
- Orthopaedic graft guide FDA UDI
- Device Name
- AUTOGRAFTER FOR HVAC TIP AUTOCLAVABLE NON STERILE FDA UDI
- Model / Reference
- 0034212 FDA UDI
- Description
- AUTOGRAFTER FOR HVAC TIP AUTOCLAVABLE NON STERILE FDA UDI
Identifiers
- Catalog Number
- 0034212 FDA UDI
- Primary DI / UDI-DI
- 00614950000135 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic graft guide 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 9 Centimeter FDA UDI
Category: Orthopaedic graft guide
Ace by Ace Surgical Supply Co., Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic graft guide.
- Arthrex® — Arthrex, Inc. · Class I
- TC-PLUS — Smith & Nephew, Inc. · Class I
- General Instruments — ALPHATEC SPINE, INC. · Class I
- Battalion — ALPHATEC SPINE, INC. · Class I
- General Instruments — ALPHATEC SPINE, INC. · Class I
- IdentiTi — ALPHATEC SPINE, INC. · Class I
- General Instruments — ALPHATEC SPINE, INC. · Class I
- General Instrument — ALPHATEC SPINE, 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
- Ace Surgical Supply Co., Inc.
Sources (1)
- FDA UDI 5722c372-e2f7-4674-92f5-586eda1d93f9 36 fields · synced May 30, 2026