SkinPen
GUDID 00863221000323
Treatment kit which includes a sterile, disposable cartridge tip, a hydrogel 510k exempt medical device, and a disposable sleeve.
BELLUS MEDICAL, LLC
Electronic cosmetic micro-needling handpiece| Primary Device ID | 00863221000323 |
| NIH Device Record Key | 6afbca98-5d85-4497-bcec-8ade7a0f83ea |
| 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 | 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 | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850035498811 [Package] Package: Mixed Case [24 Units] In Commercial Distribution |
| GS1 | 00850035498828 [Package] Package: Mixed Case [24 Units] In Commercial Distribution |
| GS1 | 00850035498866 [Package] Package: Mixed Case [12 Units] In Commercial Distribution |
| GS1 | 00863221000323 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- deNovo: DEN160029
FDA Product Code
| QAI | Powered Microneedle Device |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
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Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-04-09 |
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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