Mepilex® Ag
GUDID 07332551226954
Mepilex Ag 20x50cm, US
Mölnlycke Health Care AB
Wound-nonadherent dressing, absorbent, antimicrobial| Primary Device ID | 07332551226954 |
| NIH Device Record Key | ef1d4d19-0020-4836-9d9b-04ae467a9b38 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Mepilex® Ag |
| Version Model Number | 287500 |
| 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 |
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| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07332551226954 [Package] Contains: 07332551226961 Package: CASE [5 Units] In Commercial Distribution |
| GS1 | 07332551226961 [Package] Contains: 07332551243166 Package: PACK_OR_INNER_PACK [2 Units] In Commercial Distribution |
| GS1 | 07332551243166 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K071354
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® Ag]
| 07332551971779 | Mepilex Ag 10x12 cm, US |
| 07332551226954 | Mepilex Ag 20x50cm, US |
| 07332430612151 | Mepilex Ag 20x20 cm, US |
| 07323190132966 | Mepilex Ag 15x15 cm, US |
| 07332430612076 | Mepilex Ag 10x20 cm, US |
| 07332430612038 | Mepilex Ag 10x10 cm, 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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