SkinPen
GUDID 00863221000361
BELLUS MEDICAL, LLC
Wound hydrogel dressing, non-sterile| Primary Device ID | 00863221000361 |
| NIH Device Record Key | d9fa908c-bad9-444e-9a5b-03f5aedbfa7d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SkinPen |
| Version Model Number | 1 |
| Company DUNS | 005677967 |
| Company Name | BELLUS MEDICAL, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00863221000361 [Primary] |
| GS1 | 10863221000368 [Package] Package: [24 Units] In Commercial Distribution |
| GS1 | 20863221000365 [Package] Package: [12 Units] In Commercial Distribution |
FDA Product Code
| NAE | Dressing, Wound, Hydrogel Without Drug And/Or Biologic |
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 | 2018-12-10 |
| Device Publish Date | 2018-11-08 |
On-Brand Devices [SkinPen]
| 00863221000361 | 1 |
| 00863221000354 | 24 count of Treatment Kit singles |
| 00863221000347 | 101 |
| 00863221000330 | SkinPen Box (includes SkinPen Precision hand-piece, charging base, and AC Adapter). |
| 00863221000323 | Treatment kit which includes a sterile, disposable cartridge tip, a hydrogel 510k exempt medical |
| 00863221000316 | 100 |
| 00863221000309 | 014 |
| 20863221000327 | Case of 18 single treatment kits. |
| 10863221000320 | Case of 12 SkinPen Precision Treatment Kits |
Trademark Results [SkinPen]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SKINPEN 85922262 4532187 Live/Registered |
Bellus Medical, LLC 2013-05-03 |
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