DEVICE: OPSITE™ FLEXIGRID (05000223415433)
Device Identifier (DI) Information
OPSITE™ FLEXIGRID
4631,66024631
In Commercial Distribution
SMITH & NEPHEW MEDICAL LIMITED
4631,66024631
In Commercial Distribution
SMITH & NEPHEW MEDICAL LIMITED
Transparent dressing 15cm x 20cm, Carton of 10
Transparent dressing 6in x 8in, Carton of 10
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
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.
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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 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
f4e70bd3-e1f0-4333-b032-7623ae436f02
September 07, 2023
3
October 19, 2021
September 07, 2023
3
October 19, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | 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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined