Identity
- Trade Name
- Coveralls FDA UDI
- Generic Name
- Body-surface ultrasound imaging transducer cover FDA UDI
- Device Name
- CoverAlls 5"x48" Kit FDA UDI
- Model / Reference
- 39548 FDA UDI
- Description
- CoverAlls 5"x48" Kit FDA UDI
Identifiers
- Catalog Number
- 39548 FDA UDI
- Primary DI / UDI-DI
- 00850025153140 FDA UDI
- 510(k) Number
- K970893 FDA UDI
- FDA Product Code
- KKX FDA UDI
- GMDN Term
- Body-surface ultrasound imaging transducer cover FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4370 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Body-surface ultrasound imaging transducer cover
Coveralls by H R Pharmaceuticals, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K970893 also covers:
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- Director Biopsy/Needle Guide/Probe Cover Kit — PROTEK MEDICAL PRODUCTS, INC.
- Director Biopsy/Needle Guide/Probe Cover Kit — PROTEK MEDICAL PRODUCTS, INC.
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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 II | Pending data |
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Manufacturer
- Manufacturer
- H R Pharmaceuticals, Inc.
Sources (1)
- FDA UDI 65bfebd5-40e6-4d75-ab91-12cc40f3355d 36 fields · synced May 30, 2026