Identity
- Trade Name
- Gantry Guard Flex Mini FDA UDI
- Generic Name
- Medical equipment/instrument drape, single-use FDA UDI
- Device Name
- Sample Pack - Gantry Guard Flex Mini, CT Gantry Cover with Adhesive Tabs, 1.6mil LDPE, 109 x 82 inches, Clear, 3/pack FDA UDI
- Model / Reference
- PSCTCVR3 FDA UDI
- Description
- Sample Pack - Gantry Guard Flex Mini, CT Gantry Cover with Adhesive Tabs, 1.6mil LDPE, 109 x 82 inches, Clear, 3/pack FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10687225704622 FDA UDI
- FDA Product Code
- PUI FDA UDI
- GMDN Term
- Medical equipment/instrument drape, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4370 FDA UDI
- Commercial Distribution
- Not 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
Yes
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
Yes
FDA UDI
Gantry Guard Flex Mini by Precision Dynamics Corporation — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Precision Dynamics Corporation
Sources (1)
- FDA UDI b6aca044-575c-4792-a020-8826746d11a8 34 fields · synced May 31, 2026