sam(R) Advanced Gel Capture Patch

FDA UDI

Class II (US FDA UDI)

by ZetrOZ Systems

Identity

Trade Name: sam(R) Advanced Gel Capture Patch FDA UDI
Generic Name: Skin topical coupling gel FDA UDI
Device Name: coupling patch for use with sam wearable ultrasound device FDA UDI
Model / Reference: UB-14 FDA UDI
Description: coupling patch for use with sam wearable ultrasound device FDA UDI

Identifiers

Catalog Number: UB-14-15W FDA UDI
Primary DI / UDI-DI: 00857599005257 FDA UDI
510(k) Number: K191568 FDA UDI
FDA Product Code: PFW FDA UDI
GMDN Term: Skin topical coupling gel FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 890.5300 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Skin topical coupling gel

sam(R) Advanced Gel Capture Patch by ZetrOZ Systems — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Skin topical coupling gel.

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Clear Image Singles — NEXT Medical Products Company · Class II
Pharmaceutical Innovations — Pharmaceutical Innovations, Inc. · Class II
DynaGel™ Ultrasound Gel, 5 Liters, Clear — Dynatronics Corp. · Class II
RED Medical Supplies — Red Medical Supplies Ltd · Class II
LG — COMPASS HEALTH BRANDS CORP. · Class II
Novaplus — NEXT Medical Products Company · Class II

Cleared under the same submission

K191568 also covers:

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: ZetrOZ Systems

Sources (1)

FDA UDI 5a1ce162-2322-4575-b83d-acc336a1c739 35 fields · synced May 30, 2026