SOLOSITE 449600

GUDID 30040565115277

Wound Gel Dressing. 3oz. / 85g Non CE. Case of 12 Tubes.

SMITH & NEPHEW MEDICAL LIMITED

Wound hydrogel dressing, non-antimicrobial
Primary Device ID30040565115277
NIH Device Record Key345dbe97-3913-4199-ab93-932802c88e22
Commercial Distribution StatusIn Commercial Distribution
Brand NameSOLOSITE
Version Model Number449600
Catalog Number449600
Company DUNS216344051
Company NameSMITH & NEPHEW MEDICAL LIMITED
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100040565115276 [Primary]
GS130040565115277 [Package]
Contains: 00040565115276
Package: Case [12 Units]
In Commercial Distribution

FDA Product Code

NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-09-07
Device Publish Date2023-01-31

Devices Manufactured by SMITH & NEPHEW MEDICAL LIMITED

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05000223499396 - RENASYS2025-10-01 RENASYS WOUND+ Dressing kit with AIRLOCK Technology with foam, medium
05000223499402 - RENASYS2025-10-01 RENASYS WOUND+ Dressing kit with AIRLOCK Technology with foam, small
05000223504267 - RENASYS2025-10-01 RENASYS WOUND+ Dressing kit with AIRLOCK Technology, large
05000223504274 - RENASYS2025-10-01 RENASYS WOUND+ Dressing kit with AIRLOCK Technology, medium
05000223504281 - RENASYS2025-10-01 RENASYS WOUND+ Dressing kit with AIRLOCK Technology, small
05000223501686 - ALLEVYN™ Ag+2025-08-20 ALLEVYN AG+ 3.9IN X 3.9IN
05000223501693 - ALLEVYN™ Ag+2025-08-20 ALLEVYN AG+ 4.9IN X 4.9IN

Trademark Results [SOLOSITE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SOLOSITE
SOLOSITE
74372627 1847222 Live/Registered
SMITH & NEPHEW, INC.
1993-03-29
SOLOSITE
SOLOSITE
74014846 not registered Dead/Abandoned
Smith and Nephew United Inc.
1989-12-28

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