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Gel Pad ASSY

FDA UDI

Class III (US FDA UDI)

by Insightec

Identity

Trade Name
Gel Pad ASSY FDA UDI
Generic Name
Therapeutic oncological/gynaecological ultrasound system FDA UDI
Device Name
Transmission gel pad for single Body treatment. shipped in the following thickness (height) variants: Description Catalogue Number GEL PAD UF 25MM ASSY ASM000352-AA GEL PAD 15MM ASSY ASM000830-AA GEL PAD 40MM ASSY(Step) ASM002213 GEL PAD 45MM ASSY(Bowl) ASM000504-AA FDA UDI
Model / Reference
Gel Pad ASSY FDA UDI
Description
Transmission gel pad for single Body treatment. shipped in the following thickness (height) variants: Description Catalogue Number GEL PAD UF 25MM ASSY ASM000352-AA GEL PAD 15MM ASSY ASM000830-AA GEL PAD 40MM ASSY(Step) ASM002213 GEL PAD 45MM ASSY(Bowl) ASM000504-AA FDA UDI

Identifiers

Catalog Number
SET999014 FDA UDI
Primary DI / UDI-DI
07290015461085 FDA UDI
FDA Product Code
LSY FDA UDI
NRZ FDA UDI
GMDN Term
Therapeutic oncological/gynaecological ultrasound system FDA UDI

Classification

Device Class
Class III 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

No

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

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

Dimensions & Sizes

Size
Height — 45 Millimeter FDA UDI
Height — 40 Millimeter FDA UDI
Height — 25 Millimeter FDA UDI
Height — 15 Millimeter FDA UDI

Category: Therapeutic oncological/gynaecological ultrasound system

Gel Pad ASSY by Insightec — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Therapeutic oncological/gynaecological ultrasound system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Insightec

Sources (1)

  • FDA UDI 22548ae2-0d04-48fd-8b1d-a689c96806c7 37 fields · synced Jun 7, 2026