Identity
- Trade Name
- Shroud Kit FDA UDI
- Generic Name
- Shroud kit FDA UDI
- Device Name
- Shroud Kit that contains (1) CPE Shroud Wrap, (1) PP Chin Binder, (1) Underpad, (3) Toe Tag with 36", (2) Thread 60", Introduction Sheet, Heat-Sealed Polybag FDA UDI
- Model / Reference
- 4771 FDA UDI
- Description
- Shroud Kit that contains (1) CPE Shroud Wrap, (1) PP Chin Binder, (1) Underpad, (3) Toe Tag with 36", (2) Thread 60", Introduction Sheet, Heat-Sealed Polybag FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00616784477121 FDA UDI
- FDA Product Code
- KME FDA UDI
- GMDN Term
- Shroud kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6060 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Shroud kit
Shroud Kit by Dynarex Corp. — 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 |
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Manufacturer
- Manufacturer
- Dynarex Corp.
Sources (1)
- FDA UDI f2e31c25-671e-401a-a385-fb6c80dad861 33 fields · synced Jun 1, 2026