Ultrasound Probe Cover Biopsy Needle Guide Kit 28-GG717

by Advance Medical Designs, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00848340013591 UDI-DI	Date28 Jun 2023Listed	StatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Ultrasound Probe Cover Biopsy Needle Guide Kit
Generic Name: Medical equipment/instrument drape, single-use
Model / Reference: 28-GG717

Primary DI / UDI-DI: 00848340013591
510(k) Number: K011265
FDA Product Code: ITX
GMDN Term: Medical equipment/instrument drape, single-use

Device Class: Class II
Regulation Number: 892.1570
GUDID distribution status: In Commercial Distribution

Sterilization Method: Ethylene Oxide

From the manufacturer

Manufacturer's product page: Ultrasound Probe Covers - Additional/Other Probe Covers

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Properties

Single Use
Lot / Batch Number
Expiration Date

Other properties (11)

Sterile: No
Implantable: No
Contains Latex: No
Prescription Use: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Serial Number: No
Manufacturing Date: No