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Bundle - SingleCycle Disposable Instrument Tray and "BIOHAZARD/SOILED IN
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Bundle - SingleCycle Disposable Instrument Tray and "BIOHAZARD/SOILED IN FDA UDI
- Generic Name
- Surgical instrument containment holder, single-use, non-sterile FDA UDI
- Device Name
- Bundle - IT0612, SingleCycle Disposable Instrument Tray and "BIOHAZARD/SOILED INSTRUMENTS" tamper-proof label with adhesive backing - 100 Trays & 100 Labels FDA UDI
- Model / Reference
- IT0612-SI FDA UDI
- Description
- Bundle - IT0612, SingleCycle Disposable Instrument Tray and "BIOHAZARD/SOILED INSTRUMENTS" tamper-proof label with adhesive backing - 100 Trays & 100 Labels FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00843356101690 FDA UDI
- FDA Product Code
- PXV FDA UDI
- GMDN Term
- Surgical instrument containment holder, single-use, non-sterile FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Category: Surgical instrument containment holder, single-use, non-sterile
Bundle - SingleCycle Disposable Instrument Tray and "BIOHAZARD/SOILED IN by Cygnus Medical L.l.c. — Class I — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Surgical instrument containment holder, single-use, non-sterile.
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- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Daniels — DANIELS CORPORATION INTERNATIONAL PTY LTD · Class I
- Foam Tray Liners for IT0308, SingleCycle Disposable Instrument Tray — CYGNUS MEDICAL L.L.C. · 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 |
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Manufacturer
- Manufacturer
- Cygnus Medical L.l.c.
Sources (1)
- FDA UDI 5eeeae2b-e9e9-4d85-859b-3b0b8b7d276d 33 fields · synced May 30, 2026