OPSITE FLEXIGRID USA 10X12CM CARTON OF 10 66024629, 66024630

GUDID 05000223438517

Transparent Dressing

SMITH & NEPHEW MEDICAL LIMITED

Synthetic polymer semi-permeable film dressing, adhesive, sterile
Primary Device ID05000223438517
NIH Device Record Key8584ce2e-d2e0-4bed-bf2c-3d0ec61ed137
Commercial Distribution StatusIn Commercial Distribution
Brand NameOPSITE FLEXIGRID USA 10X12CM CARTON OF 10
Version Model Number66024629, 66024630
Catalog Number66024629, 66024630
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 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
GS105000223046293 [Package]
Contains: 05000223415419
Package: Carton 4629 [10 Units]
In Commercial Distribution
GS105000223046309 [Package]
Contains: 05000223415419
Package: Carton 4630 [50 Units]
In Commercial Distribution
GS105000223415419 [Primary]
GS105000223438517 [Package]
Contains: 05000223415419
Package: Carton 66024629 [10 Units]
In Commercial Distribution
GS105000223438524 [Package]
Contains: 05000223415419
Package: Carton 66024630 [50 Units]
In Commercial Distribution
GS105000223438722 [Package]
Contains: 05000223438524
Package: Case 66024630 [4 Units]
In Commercial Distribution
GS105000223464257 [Package]
Contains: 05000223046293
Package: Case 4629 [8 Units]
In Commercial Distribution
GS105000223464264 [Package]
Contains: 05000223046309
Package: Case 4630 [8 Units]
In Commercial Distribution
GS105000223464271 [Package]
Package: Case 66024629 [8 Units]
In Commercial Distribution

FDA Product Code

KGXTape And Bandage, Adhesive

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-14
Device Publish Date2021-06-04

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.