Iodoflex Dressing 5x5g USA 6602133005

GUDID 00040565122519

Cadexomer Iodine Pad

SMITH & NEPHEW MEDICAL LIMITED

Exudate-absorbent dressing, hydrophilic-gel, antimicrobial
Primary Device ID00040565122519
NIH Device Record Key5922bb91-a49d-42e0-86f3-fdd0758dfb93
Commercial Distribution StatusIn Commercial Distribution
Brand NameIodoflex Dressing 5x5g USA
Version Model Number6602133005
Catalog Number6602133005
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 Producttrue
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
GS100040565122502 [Primary]
GS100040565122519 [Package]
Contains: 00040565122502
Package: Carton [5 Units]
In Commercial Distribution
GS130040565122510 [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 Date2021-06-21
Device Publish Date2020-09-18

Devices Manufactured by SMITH & NEPHEW MEDICAL LIMITED

05000223503178 - ALLEVYN COMPLETE CARE2025-08-07 ALLEVYN COMPLETE CARE M 12.5x12.5 CTN10 silicone gel adhesive composite hydrocellular foam dressing
05000223503185 - ALLEVYN COMPLETE CARE2025-08-07 ALLEVYN COMPLETE CARE L 15x15 CTN10 silicone gel adhesive composite hydrocellular foam dressing
05000223503086 - ALLEVYN COMPLETE CARE2025-08-07 ALLEVYN COMPLETE CARE XL 17.5cm x 17.5cm CTN 10
05000223503093 - ALLEVYN COMPLETE CARE2025-08-07 ALLEVYN COMPLETE CARE S RECT 10x20 CTN10 silicone gel adhesive composite hydrocellular foam dressing
05000223503215 - ALLEVYN COMPLETE CARE L Rectangle 10cm x 30cm CTN 102025-08-07 ALLEVYN COMPLETE CARE RECT L 10x30 CTN10 silicone gel adhesive composite hydrocellular foam dressing
05000223503222 - ALLEVYN COMPLETE CARE2025-08-07 ALLEVYN COMPLETECARE MULTI 17.1x17.8 CTN10 silicone gel adhesive composite hydrocellular foam dressing
05000223503123 - ALLEVYN COMPLETE CARE2025-08-07 ALLEVYN COMPLETECARE SCRM 17.2x17.4 CTN10 silicone gel adhesive composite hydrocellular foam dressing
05000223503130 - ALLEVYN COMPLETE CARE2025-08-07 ALLEVYN COMPLETECARE SCRM 21.5x23.0 CTN10 silicone gel adhesive composite hydrocellular foam dressing

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.