Identity
- Trade Name
- STAT-PAC™ FDA UDI
- Generic Name
- Operating room turnover kit FDA UDI
- Device Name
- Room Turnover Pack FDA UDI
- Model / Reference
- SP3251 FDA UDI
- Description
- Room Turnover Pack FDA UDI
Identifiers
- Catalog Number
- SP3251 FDA UDI
- Primary DI / UDI-DI
- 10076490616738 FDA UDI
- GMDN Term
- Operating room turnover kit FDA UDI
Classification
- 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Operating room turnover kit
Stat-Pac™ by Ansell Healthcare Product — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Bosma Enterprises — Bosma Enterprises · Class I
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- Alleset — GRI Medical & Electronic Technology Co., Ltd. · Class I
- Bosma Enterprises — Bosma Enterprises · 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Ansell Healthcare Product
Sources (1)
- FDA UDI af154dbe-067c-4ca3-af7d-50baa6170e69 35 fields · synced Jun 1, 2026