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SingleCycle Disposable Instrument Tray with Soiled Instrument Sticker
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- SingleCycle Disposable Instrument Tray with Soiled Instrument Sticker FDA UDI
- Generic Name
- Surgical instrument containment holder, single-use, non-sterile FDA UDI
- Device Name
- SingleCycle Disposable Instrument Tray (O.Dim. 15.25 X 18.85 x 3.0, I.Dim. 13.13 x 7.13 x 2.75) with Soiled Instrument Sticker - 60 Trays & 60 Stickers FDA UDI
- Model / Reference
- IT0713-SI FDA UDI
- Description
- SingleCycle Disposable Instrument Tray (O.Dim. 15.25 X 18.85 x 3.0, I.Dim. 13.13 x 7.13 x 2.75) with Soiled Instrument Sticker - 60 Trays & 60 Stickers FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00843356100693 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
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
Category: Surgical instrument containment holder, single-use, non-sterile
SingleCycle Disposable Instrument Tray with Soiled Instrument Sticker by Cygnus Medical L.l.c. — Class I — FDA UDI — listed in FDA GUDID
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Also classified as Surgical instrument containment holder, single-use, non-sterile.
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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 b8263f16-272f-4451-9904-e3492b932c91 33 fields · synced Jun 8, 2026