Mepilex® Transfer Ag
GUDID 07323190013395
Mepilex Transfer Ag 20x50cm US
Mölnlycke Health Care AB
Wound-nonadherent dressing, permeable, antimicrobial| Primary Device ID | 07323190013395 |
| NIH Device Record Key | 50151424-b745-42c7-9e93-23a8236e88b3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Mepilex® Transfer Ag |
| Version Model Number | 394590 |
| Company DUNS | 631770658 |
| Company Name | Mölnlycke Health Care AB |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07323190013395 [Package] Contains: 07323190013401 Package: CASE [6 Units] In Commercial Distribution |
| GS1 | 07323190013401 [Package] Contains: 07323190018833 Package: PACK_OR_INNER_PACK [2 Units] In Commercial Distribution |
| GS1 | 07323190018833 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K123892
FDA Product Code
| FRO | Dressing, wound, drug |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-31 |
| Device Publish Date | 2022-10-21 |
On-Brand Devices [Mepilex® Transfer Ag]
| 07323190013395 | Mepilex Transfer Ag 20x50cm US |
| 07323190013531 | Mepilex Transfer Ag 15x20cm, US |
| 07323190013203 | Mepilex Transfer Ag 10x12,5cm US |
Trademark Results [Mepilex]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MEPILEX 77850168 3820862 Live/Registered |
Mölnlycke Health Care AB 2009-10-16 |
 MEPILEX 75582163 2346713 Dead/Cancelled |
Molnlycke Health Care AB 1998-11-03 |
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