DEVICE: OPSITE™ FLEXIGRID (05000223415433)

Device Identifier (DI) Information

OPSITE™ FLEXIGRID
4631,66024631
In Commercial Distribution

SMITH & NEPHEW MEDICAL LIMITED
05000223415433
GS1

1
216344051 *Terms of Use
Transparent dressing 15cm x 20cm, Carton of 10 Transparent dressing 6in x 8in, Carton of 10
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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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
KGX Tape And Bandage, Adhesive
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FDA Premarket Submission

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

Sterilization

Yes
Yes
Sterilization Method [?]
Ethylene Oxide
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

f4e70bd3-e1f0-4333-b032-7623ae436f02
September 07, 2023
3
October 19, 2021
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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