AccessGUDID - DEVICE: OPSITE™ FLEXIGRID (05000223415433)

GUDID

Device Identifier (DI) Information

Brand Name: OPSITE™ FLEXIGRID
Version or Model: 4631,66024631
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SMITH & NEPHEW MEDICAL LIMITED

Primary DI Number: 05000223415433
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 216344051 *Terms of Use

Device Description: Transparent dressing 15cm x 20cm, Carton of 10 Transparent dressing 6in x 8in, Carton of 10

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58301	Synthetic polymer semi-permeable film dressing, adhesive	A transparent, semi-permeable (i.e., impermeable to fluids, permeable to vapours and gases) covering applied to wounded or diseased tissue intended to provide protection (e.g., from dirt, water) and/or promote healing. It is a thin, clear film made of synthetic polymer material that is covered on one side with a pressure-sensitive adhesive. It may be applied directly to tissue or used in combination with other dressings (e.g., gauze) to protect postsurgical incisions and minor wounds (e.g., cuts, scrapes, burns, skin tears, blisters). It may also be used to secure to skin other devices such as vascular catheters, infusion ports, or tubing. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KGX	Tape And Bandage, Adhesive

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f4e70bd3-e1f0-4333-b032-7623ae436f02
Public Version Date: September 07, 2023
Public Version Number: 3
DI Record Publish Date: October 19, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
05000223046316	10	05000223415433	In Commercial Distribution	Carton 4631
05000223414849	10	05000223046316	In Commercial Distribution	Case 4631
05000223438548	10	05000223415433	In Commercial Distribution	Carton 66024631
05000223438746	10	05000223438548	In Commercial Distribution	Case 66024631