Identity
- Trade Name
- Ultrasound Probe Cover Biopsy Needle Guide Kit FDA UDI
- Generic Name
- Medical equipment handle cover, single-use FDA UDI
- Device Name
- Disposable Probe Cover Accessories FDA UDI
- Model / Reference
- 28-EG189 FDA UDI
- Description
- Disposable Probe Cover Accessories FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848340017537 FDA UDI
- 510(k) Number
- K011265 FDA UDI
- FDA Product Code
- ITX FDA UDI
- GMDN Term
- Medical equipment handle cover, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Category: Medical equipment handle cover, single-use
Ultrasound Probe Cover Biopsy Needle Guide Kit by Advance Medical Designs, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Medical equipment handle cover, single-use.
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Cleared under the same submission
K011265 also covers:
- Probe Cover — Advance Medical Designs, Inc.
- Probe Cover — Advance Medical Designs, Inc.
- Rolled Probe Cover — Advance Medical Designs, Inc.
- Soft Flex Probe Cover — Advance Medical Designs, Inc.
- Soft Flex Probe Cover — Advance Medical Designs, Inc.
- Ultrasound Probe Cover Biopsy Needle Guide — Advance Medical Designs, Inc.
- Ultrasound Probe Cover Biopsy Needle Guide — Advance Medical Designs, Inc.
- Ultrasound Probe Cover Biopsy Needle Guide — Advance Medical Designs, Inc.
- Ultrasound Probe Cover Biopsy Needle Guide — Advance Medical Designs, Inc.
- Ultrasound Probe Cover Biopsy Needle Guide — Advance Medical Designs, Inc.
- Ultrasound Probe Cover Biopsy Needle Guide — Advance Medical Designs, Inc.
- Ultrasound Probe Cover Biopsy Needle Guide — Advance Medical Designs, Inc.
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
- Advance Medical Designs, Inc.
Sources (1)
- FDA UDI 5201cc37-0292-490e-b73e-51ba3310f11d 34 fields · synced Jun 8, 2026