Identity
- Trade Name
- Gantry Guard FDA UDI
- Generic Name
- Medical equipment/instrument drape, single-use FDA UDI
- Device Name
- GANTRY GUARD CT GANTRY COVER 1.6 MIL WITH ADHESIVE TABS PLASTIC 296 CM X 206 CM CLEAR FDA UDI
- Model / Reference
- CTG01 FDA UDI
- Description
- GANTRY GUARD CT GANTRY COVER 1.6 MIL WITH ADHESIVE TABS PLASTIC 296 CM X 206 CM CLEAR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10687225325087 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 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 552eda9c-f1ca-4677-8fde-92a81b457872 34 fields · synced May 29, 2026