DEVICE: ALLEVYN Gentle Border Heel (05000223465230)

Device Identifier (DI) Information

ALLEVYN Gentle Border Heel
66020407
In Commercial Distribution
66020407, 66800506
SMITH & NEPHEW MEDICAL LIMITED
05000223465230
GS1

1
216344051 *Terms of Use
ALLEVYN Gentle Border Heel Silicone gel adhesive hydrocellular foam heel dressing
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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?
44970 Exudate-absorbent dressing, non-gel, non-antimicrobial
A wound covering intended to assist in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) and often by creating a moist wound-healing environment. It is not in the form of a gel and does not produce a water-absorbent gel upon contact with wound exudates, but may be designed to absorb and remove exudates (e.g., by capillary action); it does not contain an antimicrobial agent, but may include antioxidant properties. The device is available in a variety of forms (e.g., flat sheet/film-like, impregnated pouches, filled sachets, lyophilized matrix, ribbon, rope, foam, liquid, or powder). After application, this device cannot be reused.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
NAD Dressing, Wound, Occlusive
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FDA Premarket Submission

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

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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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

d6d6b619-77ca-4ece-82c7-1dff0e72c385
September 07, 2023
6
July 04, 2019
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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
05000223482961 5 05000223465230 In Commercial Distribution Carton
05000223465247 5 05000223465230 In Commercial Distribution Carton 66800506
05000223465254 7 05000223465247 In Commercial Distribution Case 66800506
05000223482978 7 05000223482961 In Commercial Distribution case 66020407
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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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