Identity
- Trade Name
- BIRTHING MAT- STRYKER GYNNIE SET -POLYC FDA UDI
- Generic Name
- Flame-resistant bed mattress FDA UDI
- Device Name
- BIRTHING MATTRESS STRYKER GYNNIE SET (INCL MAIN PAD & THIGH PAD)-POLYCARB FDA UDI
- Model / Reference
- BRM-GYNNIE-SET-PC FDA UDI
- Description
- BIRTHING MATTRESS STRYKER GYNNIE SET (INCL MAIN PAD & THIGH PAD)-POLYCARB FDA UDI
Identifiers
- Catalog Number
- 27266 FDA UDI
- Primary DI / UDI-DI
- 00840828185035 FDA UDI
- FDA Product Code
- IKY FDA UDI
- GMDN Term
- Flame-resistant bed mattress FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5150 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Flame-resistant bed mattress
Birthing Mat- Stryker Gynnie Set -polyc by Curbell Medical Products, Inc. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Curbell Medical Products, Inc.
Sources (1)
- FDA UDI 467e85e2-6b32-4cb7-9ef9-1f8f8fd5c57d 35 fields · synced May 31, 2026