Iodoflex Dressing 3x10g USA 6602134010

GUDID 00040565122533

Cadexomer Iodine Pad

SMITH & NEPHEW MEDICAL LIMITED

Exudate-absorbent dressing, hydrophilic-gel, antimicrobial
Primary Device ID00040565122533
NIH Device Record Key644c8bd7-732a-4fff-ae1a-574de9473430
Commercial Distribution StatusIn Commercial Distribution
Brand NameIodoflex Dressing 3x10g USA
Version Model Number6602134010
Catalog Number6602134010
Company DUNS216344051
Company NameSMITH & NEPHEW MEDICAL LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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
GS100040565122526 [Primary]
GS100040565122533 [Package]
Contains: 00040565122526
Package: Carton [3 Units]
In Commercial Distribution
GS130040565122534 [Package]
Package: Case [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRODressing, Wound, Drug

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-04-20
Device Publish Date2020-09-18

Devices Manufactured by SMITH & NEPHEW MEDICAL LIMITED

00040565117706 - COVRSITE2026-01-27 COVRSITE DRESSING 4X4 BOX 10
00040565117744 - COVRSITE2026-01-27 CovRSite Dressing 6 x 6 CTN10
00040565120256 - COVRSITE2026-01-27 CovRSite Plus Dressing 4 x 4 CTN10
00040565120270 - COVRSITE2026-01-27 CovRSite Plus Dressing 6 x 6 CTN10
00500223504335 - NOVIX2026-01-21 NOVIX PRIMER AND CLEANSER 4OZ
05000223502713 - No Sting Skin Prep2025-12-04 NO-STING SKIN PREP SPRAY 28ML US
05000223499389 - RENASYS2025-10-01 RENASYS WOUND+ Dressing kit with AIRLOCK Technology with foam, large
05000223499396 - RENASYS2025-10-01 RENASYS WOUND+ Dressing kit with AIRLOCK Technology with foam, medium

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.