Identity
- Trade Name
- Alleset FDA UDI
- Generic Name
- Operating room turnover kit FDA UDI
- Device Name
- Gel Wheelchair Cushion_black_22inx18inx3in_4ea/cs FDA UDI
- Model / Reference
- GWC2218-3 FDA UDI
- Description
- Gel Wheelchair Cushion_black_22inx18inx3in_4ea/cs FDA UDI
Identifiers
- Primary DI / UDI-DI
- 16931918123448 FDA UDI
- FDA Product Code
- IMP FDA UDI
- GMDN Term
- Operating room turnover kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3920 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Operating room turnover kit
Alleset by GRI Medical & Electronic Technology Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- STAT-PAC™ — Ansell Healthcare Product
- Bosma Enterprises — Bosma Enterprises · Class I
- Bosma Enterprises — Bosma Enterprises · Class I
- RTK10167 Room Turnover Kit — XODUS MEDICAL, INC. · Class I
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
- GRI Medical & Electronic Technology Co., Ltd.
Sources (1)
- FDA UDI 152f1b38-b1e9-42cc-934e-63d898806827 34 fields · synced Sep 18, 2026