Identity
- Trade Name
- Multi Angle Biopsy Starter Kit FDA UDI
- Generic Name
- Body-surface ultrasound imaging transducer cover FDA UDI
- Device Name
- Multi Angle Biopsy Starter Kit for Samsung Medison CA1-7A/CA1-7AD Ultrasound Transducers FDA UDI
- Model / Reference
- 7167 FDA UDI
- Description
- Multi Angle Biopsy Starter Kit for Samsung Medison CA1-7A/CA1-7AD Ultrasound Transducers FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841912103522 FDA UDI
- GMDN Term
- Body-surface ultrasound imaging transducer cover FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
High-level Disinfectant FDA UDI
Category: Needle guide, single-useUltrasound imaging system tracking positioner, reusableBody-surface ultrasound imaging transducer cover
Multi Angle Biopsy Starter Kit by Protek Medical Products, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Body-surface ultrasound imaging transducer cover.
- Sheathes3D — Sheathing Technologies, Inc. · Class II
- Sheathes — Sheathing Technologies, Inc. · Class II
- Sheathes — Sheathing Technologies, Inc. · Class II
- Sheathes — Sheathing Technologies, Inc. · Class II
- Sheathes — Sheathing Technologies, Inc. · Class II
- Sheathes3D — Sheathing Technologies, Inc. · Class II
- Sheathes3D — Sheathing Technologies, Inc. · Class II
- Sheathes3D — Sheathing Technologies, Inc. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Protek Medical Products, Inc.
Sources (1)
- FDA UDI db4a0ba6-8cf6-44a4-a8f2-87476f6a6c49 34 fields · synced May 31, 2026