Identity
- Trade Name
- HEPRO.US Welcome Pack FDA UDI
- Generic Name
- Surgical/examination garment kit FDA UDI
- Device Name
- Welcome Pack 1 Pouch 5 pcs Included FDA UDI
- Model / Reference
- Single Pouch Welcome Pack FDA UDI
- Description
- Welcome Pack 1 Pouch 5 pcs Included FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00854427007896 FDA UDI
- FDA Product Code
- ERY FDA UDI
- GMDN Term
- Surgical/examination garment kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4370 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: Surgical/examination garment kit
HEPRO.US Welcome Pack by Hepro.us Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 II | Pending data |
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Manufacturer
- Manufacturer
- Hepro.us Inc.
Sources (1)
- FDA UDI 049bbaef-b64c-463f-aa78-56e0e6b3c953 33 fields · synced Jun 1, 2026