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Synergy MSK Ultrasound Strl Cover & Parker Gel

FDA UDI

Class II (US FDA UDI)

by SAFERSONIC Medizinprodukte Handels GmbH

Identity

Trade Name
Synergy MSK Ultrasound Strl Cover & Parker Gel FDA UDI
Generic Name
Topical coupling gel, sterile FDA UDI
Device Name
Sterile ultrasound probe cover and ultrasound gel. FDA UDI
Model / Reference
AR-3500-50D-US FDA UDI
Description
Sterile ultrasound probe cover and ultrasound gel. FDA UDI

Identifiers

Primary DI / UDI-DI
B748AR350050DUS0 FDA UDI
510(k) Number
K092858 FDA UDI
FDA Product Code
ITX FDA UDI
GMDN Term
Topical coupling gel, sterile 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

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

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

Yes

FDA UDI

Category: Topical coupling gel, sterile

Synergy MSK Ultrasound Strl Cover & Parker Gel by SAFERSONIC Medizinprodukte Handels GmbH — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Topical coupling gel, sterile.

Cleared under the same submission

K092858 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
SAFERSONIC Medizinprodukte Handels GmbH

Sources (1)

  • FDA UDI d9d369c5-c784-4f2f-8ac1-591c8bbc55fe 34 fields · synced May 29, 2026