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Water-Jel

FDA UDI

Class U (US FDA UDI)

by Water-Jel Technologies, L.l.c.

Identity

Trade Name
Water-Jel FDA UDI
Generic Name
Burn gel FDA UDI
Device Name
Cool Jel unit dose 100 bxs of 6 (600 pcs per case); Cool Jel FDA UDI
Model / Reference
CJ6-600.00.000 FDA UDI
Description
Cool Jel unit dose 100 bxs of 6 (600 pcs per case); Cool Jel FDA UDI

Identifiers

Catalog Number
CJ6-600.00.000 FDA UDI
Primary DI / UDI-DI
00743537001019 FDA UDI
510(k) Number
K003396 FDA UDI
FDA Product Code
MGQ FDA UDI
GMDN Term
Burn gel FDA UDI

Classification

Device Class
U 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

Yes

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

Category: Burn gel

Water-Jel by Water-Jel Technologies, L.l.c. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Burn gel.

Cleared under the same submission

K003396 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Water-Jel Technologies, L.l.c.

Sources (1)

  • FDA UDI c77a9f24-9148-4563-b06f-01cd64860b3c 36 fields · synced May 31, 2026