DEVICE: Medline (10080196323173)

Device Identifier (DI) Information

Medline
MSC94812EP
In Commercial Distribution
MSC94812EP
MEDLINE INDUSTRIES, INC.
10080196323173
GS1

1
025460908 *Terms of Use
DRESSING,MAXORB EXTRA AG,SILVER ALG,8X12
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
Yes
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?
47474 Exudate-absorbent dressing, hydrophilic-gel, antimicrobial
A wound covering, typically made of a hydrocolloid, hydrofibre, chitosan or alginate (salts and acids extracted from seaweed), intended to produce a water-absorbent gel upon contact with wound exudate, and that contains an antimicrobial agent [e.g., silver (Ag), honey]. It assists in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) for minimal wound maceration, allowing wound debridement, and creating a moist wound-healing environment while reducing microbial colonization within the dressing. The device may be in the form of a flat sheet/film, 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
FRO Dressing, wound, drug
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K070581 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Store at room temperature. Keep dry. Do not store above 77 F/25 C.
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Clinically Relevant Size

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

f936e4b9-64ef-4a57-959c-3481d5dad395
October 28, 2021
1
October 20, 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
40080196323174 50 30080196323177 In Commercial Distribution CASE
30080196323177 5 10080196323173 In Commercial Distribution BOX
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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

[?]
+1(800)633-5463
service@medline.com
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