Identity
- Trade Name
- RACK FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- Rack - MRS EUDAMEDA surgical instrument rack is a specialized device used in healthcare settings, particularly in sterile processing departments and operating rooms. Its primary function is to hold and organize surgical instruments during cleaning, sterilization, and storage. FDA UDI
- Model / Reference
- MRS-101 EUDAMEDFDA UDI
- Description
- A surgical instrument rack is a specialized device used in healthcare settings, particularly in sterile processing departments and operating rooms. Its primary function is to hold and organize surgical instruments during cleaning, sterilization, and storage. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810019931451 EUDAMEDFDA UDI
- Basic UDI-DI
- 081001993MRS101YG EUDAMED
- Direct Marketing DI
- 00810019931451 EUDAMED
- FDA Product Code
- FSM FDA UDI
- EMDN Code
- L1206 LAPAROSCOPIC AND THORACOSCOPIC SURGERY SPREADERS AND RETRACTORS, REUSABLE EUDAMED
- GMDN Term
- Instrument tray, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
Rack by Bradshaw Medical 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 |
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Manufacturer
- Manufacturer
- Bradshaw Medical Inc.
Sources (2)
- FDA UDI 9b245548-3c19-4516-a44f-a76e827b5fe5 33 fields · synced Jul 12, 2026
- EUDAMED 98a9a76c-26d8-432b-aba4-68cb24e0f83d 61 fields · synced Jul 12, 2026