Identity
- Trade Name
- Vashe Sterile Sleeve FDA UDI
- Generic Name
- Medical equipment/instrument drape, single-use FDA UDI
- Device Name
- The Vashe Sterile Sleeve is an optional accessory for Vashe Wound Solution. The Sleeve is a sterile drape fitted with a spiked cap and nozzle tip. The Sleeve can be aseptically fitted over an instillation bottle of Vashe Wound Solution to render the outside of the bottle sterile so it may be brought into a sterile field. The spiked cap is aseptically pushed through the septum cap of the bottle, and the sterile splash guard placed over the nozzle tip. FDA UDI
- Model / Reference
- 00355 FDA UDI
- Description
- The Vashe Sterile Sleeve is an optional accessory for Vashe Wound Solution. The Sleeve is a sterile drape fitted with a spiked cap and nozzle tip. The Sleeve can be aseptically fitted over an instillation bottle of Vashe Wound Solution to render the outside of the bottle sterile so it may be brought into a sterile field. The spiked cap is aseptically pushed through the septum cap of the bottle, and the sterile splash guard placed over the nozzle tip. FDA UDI
Identifiers
- Catalog Number
- 00355 FDA UDI
- Primary DI / UDI-DI
- 00190769003555 FDA UDI
- FDA Product Code
- HMW FDA UDI
- GMDN Term
- Medical equipment/instrument drape, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4370 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Vashe Sterile Sleeve by Urgo Medical North America, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 II | Pending data |
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Manufacturer
- Manufacturer
- Urgo Medical North America, LLC
Sources (1)
- FDA UDI ef0eb1a7-b6c2-483f-9966-2edcdfc2ecc5 36 fields · synced Jun 9, 2026