Black & Black Surgical
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Black & Black Surgical FDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Device Name
- STERILIZATION TRAY STAINLESS STEEL: 20.4" X 9.5" X 2.75", LID, SILICONE MAT FDA UDI
- Model / Reference
- B66335 EUDAMEDFDA UDIInstrument tray, reusable EUDAMED
- Description
- STERILIZATION TRAY STAINLESS STEEL: 20.4" X 9.5" X 2.75", LID, SILICONE MAT FDA UDI
Identifiers
- Catalog Number
- B66335 FDA UDI
- Primary DI / UDI-DI
- 00840329829377 EUDAMEDFDA UDI
- Basic UDI-DI
- 08403298011102J2 EUDAMED
- FDA Product Code
- FSM FDA UDI
- EMDN Code
- V0402 CLINICAL USE TRAYS AND BOWLS EUDAMED
- GMDN Term
- Device sterilization/disinfection container, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Device sterilization/disinfection container, reusable
Black & Black Surgical by Black & Black Surgical, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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
- Black & Black Surgical, Inc.
Sources (2)
- FDA UDI 1900e7d2-e382-431b-9ce7-1ce9ecbe7221 35 fields · synced Jul 9, 2026
- EUDAMED bafc790d-26d8-4f0a-9528-f42940cf1f0c 61 fields · synced Jul 9, 2026