Identity
- Trade Name
- Orthopediatrics Instrumentation FDA UDI
- Generic Name
- Tendon/ligament tunneller FDA UDI
- Device Name
- Tendon Passer, 2.4mm x 400mm FDA UDI
- Model / Reference
- 01-1007-0213 FDA UDI
- Description
- Tendon Passer, 2.4mm x 400mm FDA UDI
Identifiers
- Catalog Number
- 01-1007-0213 FDA UDI
- Primary DI / UDI-DI
- 00841132174418 FDA UDI
- FDA Product Code
- HWQ FDA UDI
- GMDN Term
- Tendon/ligament tunneller 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
Category: Tendon/ligament tunneller
Orthopediatrics Instrumentation by Orthopediatrics Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tendon/ligament tunneller.
- Perfix™ MIS — CG MedTech Co., Ltd. · Class I
- V. Mueller — STERIS CORPORATION · Class I
- Perfix™ MIS — CG MedTech Co., Ltd. · Class I
- Surgical Direct — SURGICAL DIRECT, INC. · Class I
- BOSS Instruments — Boss Instruments, Ltd. · Class I
- Perfix™ MIS — CG MedTech Co., Ltd. · Class I
- Polarfix™ Facet Screw System — CG MedTech Co., Ltd. · Class I
- Surgical Direct — SURGICAL DIRECT, 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
- Orthopediatrics Corp.
Sources (1)
- FDA UDI 8739368a-3da9-4630-bf9c-ec40f8e9bd5a 35 fields · synced Jun 6, 2026