Identity
- Trade Name
- INSTRUMENT FDA UDI
- Generic Name
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. FDA UDI
- Model / Reference
- Curette, rectangular upward angled FDA UDI
- Description
- An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. FDA UDI
Identifiers
- Catalog Number
- P007AX FDA UDI
- Primary DI / UDI-DI
- 04047844055625 FDA UDI
- FDA Product Code
- HRT FDA UDI
- GMDN Term
- Orthopaedic surgical procedure kit, non-medicated, reusable 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic surgical procedure kit, non-medicated, reusable
Instrument by SIGNUS Medizintechnik GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic surgical procedure kit, non-medicated, reusable.
- Knee Instruments — Medacta International · Class I
- Arthrex® — Arthrex, Inc. · Class I
- Spine Instruments — Medacta International · Class I
- Knee Instruments — Medacta International · Class I
- RAZEK EQUIPAMENTOS — RAZEK EQUIPAMENTOS LTDA · Class I
- General Instruments — ORTHOPEDIATRICS CORP. · Class I
- Hip Instruments — Medacta International · Class I
- ORTHOPEDIC MANUAL SURGICAL INSTRUMENT — FX SOLUTIONS · 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
- SIGNUS Medizintechnik GmbH
Sources (1)
- FDA UDI 98e57457-9be1-48fb-8831-27576dec4672 37 fields · synced May 30, 2026