Mepore® Film
GUDID 07332551950200
Normlgel Ag 45g
Mölnlycke Health Care AB
Wound hydrogel dressing, antimicrobial| Primary Device ID | 07332551950200 |
| NIH Device Record Key | 21f174a1-37b2-43b3-8688-00f154323a90 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Mepore® Film |
| Version Model Number | 350450 |
| 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 | false |
| 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
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| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07332551950194 [Package] Package: CASE [3 Units] In Commercial Distribution |
| GS1 | 07332551950200 [Package] Contains: 07332551958503 Package: PACK_OR_INNER_PACK [10 Units] In Commercial Distribution |
| GS1 | 07332551958503 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K110458
FDA Product Code
| FRO | Dressing, wound, drug |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
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 [Mepore® Film]
| 07332551950200 | Normlgel Ag 45g |
| 07323190291823 | Mepore Film 15x20 cm |
| 07323190291892 | Mepore Film 10x25 cm |
| 07323190291960 | Mepore Film 10x12 cm |
| 07323190292042 | Mepore Film 6x7 cm |
| 07323190295104 | Unit pack Mepore Film 15x20 cm |
| 07323190295043 | Unit pack Mepore Film 10x25 cm |
| 07323190294992 | Unit pack Mepore Film 10x12 cm |
| 07323190294831 | Unit pack Mepore Film 6x7cm |
| 07333350722098 | Unit pack Mepore Film 20x30 cm |
Trademark Results [Mepore]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MEPORE 79022307 3194683 Live/Registered |
Mölnlycke Health Care AB 2006-02-03 |
 MEPORE 75179736 not registered Dead/Abandoned |
SCA Molnlycke AB 1996-10-10 |
 MEPORE 74110812 1657995 Live/Registered |
MOLNLYCKE HEALTH CARE AB 1990-10-30 |
 MEPORE 73416701 1306759 Dead/Cancelled |
Molnlycke Aktiebolag 1983-03-10 |
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