← Back to catalogue
Sigma
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 9505-02-815Model TruMatch Instrument Case/Tray
Identity
- Trade Name
- SIGMA FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- Instrument Case/Tray EUDAMEDSIGMA HIGH PERFORMANCE RP-F TRIALS CASE FDA UDI
- Model / Reference
- 9505-02-815 EUDAMEDFDA UDITruMatch Instrument Case/Tray EUDAMED
- Description
- SIGMA HIGH PERFORMANCE RP-F TRIALS CASE FDA UDI
Identifiers
- Catalog Number
- 950502815 FDA UDI
- Primary DI / UDI-DI
- 10603295229438 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a000107R EUDAMED
- Direct Marketing DI
- 10603295229438 EUDAMED
- FDA Product Code
- FSM FDA UDI
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Instrument tray, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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: Instrument tray, reusable
Sigma by Depuy Orthopaedics, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Instrument tray, reusable.
- MİKRO — SAMSUN MİKRO CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
- Hu-Friedy — Hu-Friedy Manufacturing Co., LLC · Class I
- Instrument Case — Katena Products, Inc. · Class I
- Hu-Friedy — Hu-Friedy Manufacturing Co., LLC · Class I
- MİKRO — SAMSUN MİKRO CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
- SHEFFIELD RING FIXATOR — Orthofix, Inc. · Class II
- MİKRO — SAMSUN MİKRO CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
- ASELTECH — Asel Tibbi Aletler A.S. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| 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
- Depuy Orthopaedics, Inc.
Sources (2)
- FDA UDI c4d50c52-3423-405b-ad34-d42dee75873b 35 fields · synced Jun 19, 2026
- EUDAMED 0fcc5943-a71b-4f72-b8c3-b3f551575c45 61 fields · synced Jun 19, 2026