DEVICE: Medline (10080196323173)
Device Identifier (DI) Information
Medline
MSC94812EP
In Commercial Distribution
MSC94812EP
MEDLINE INDUSTRIES, INC.
MSC94812EP
In Commercial Distribution
MSC94812EP
MEDLINE INDUSTRIES, INC.
DRESSING,MAXORB EXTRA AG,SILVER ALG,8X12
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 |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| FRO | Dressing, wound, drug |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K070581 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Special Storage Condition, Specify: Store at room temperature. Keep dry. Do not store above 77 F/25 C. |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
f936e4b9-64ef-4a57-959c-3481d5dad395
October 28, 2021
1
October 20, 2021
October 28, 2021
1
October 20, 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 |
|---|---|---|---|---|---|
| 40080196323174 | 50 | 30080196323177 | In Commercial Distribution | CASE | |
| 30080196323177 | 5 | 10080196323173 | In Commercial Distribution | BOX |
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
[?]
+1(800)633-5463
service@medline.com
service@medline.com