← Back to catalogue
BAROVAC® Evacuator Closed Wound Drainage System(SS)
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- BAROVAC® Evacuator Closed Wound Drainage System(SS) FDA UDI
- Generic Name
- Ethanol (ETOH) IVD, kit, rapid spectrophotometry, clinical FDA UDI
- Model / Reference
- SS100M+(3.2) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806369452021 FDA UDI
- FDA Product Code
- GCY FDA UDI
- GMDN Term
- Ethanol (ETOH) IVD, kit, rapid spectrophotometry, clinical FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4680 FDA UDI
- Commercial Distribution
- 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ethanol (ETOH) IVD, kit, rapid spectrophotometry, clinical
BAROVAC® Evacuator Closed Wound Drainage System(SS) by Sewoon Medical Co., Ltd. — Class I — 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sewoon Medical Co., Ltd.
Sources (1)
- FDA UDI a7dc9215-cd09-4c74-a9a1-e1d9a09d9fd4 32 fields · synced May 30, 2026