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Batrik Level 2 Ultrasonically WeldedSeam\Blue Gown\Size M
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Batrik Level 2 Ultrasonically WeldedSeam\Blue Gown\Size M FDA UDI
- Generic Name
- Isolation gown, single-use FDA UDI
- Device Name
- Level 2 Protective Gowns, Medium, Blue FDA UDI
- Model / Reference
- SF-202-M FDA UDI
- Description
- Level 2 Protective Gowns, Medium, Blue FDA UDI
Identifiers
- Catalog Number
- SF-202-M FDA UDI
- Primary DI / UDI-DI
- 00690521018075 FDA UDI
- FDA Product Code
- OEA FDA UDI
- GMDN Term
- Isolation gown, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4040 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Isolation gown, single-use
Batrik Level 2 Ultrasonically WeldedSeam\Blue Gown\Size M by Batrik Medical Manufacturing Inc — Class I — FDA UDI — listed in FDA GUDID
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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
- Batrik Medical Manufacturing Inc
Sources (1)
- FDA UDI 10fc7dc6-50f4-4b0b-aec3-e652efb7b8b9 36 fields · synced Jun 8, 2026