Primary Device ID | 10850035498290 |
NIH Device Record Key | 4fb72c7a-678a-4198-a500-185a38ffc9f5 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SP MicroPen EVO Microneedling Cartridge |
Version Model Number | F5SP223 |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00850035498279 [Primary] |
GS1 | 00850035498293 [Package] Contains: 00850035498279 Package: [1 Units] In Commercial Distribution |
GS1 | 00850035498323 [Package] Package: Mixed Case [1 Units] In Commercial Distribution |
GS1 | 00850035498330 [Package] Package: Case [2 Units] In Commercial Distribution |
GS1 | 00850035498804 [Package] Package: Mixed Case [2 Units] In Commercial Distribution |
GS1 | 00850035498835 [Package] Package: Mixed Case [2 Units] In Commercial Distribution |
GS1 | 00850035498842 [Package] Contains: 00850035498279 Package: Mixed Case [1 Units] In Commercial Distribution |
GS1 | 00850035498859 [Package] Contains: 00850035498279 Package: Mixed Case [1 Units] In Commercial Distribution |
GS1 | 00850035498880 [Package] Contains: 00850035498279 Package: Each [1 Units] In Commercial Distribution |
GS1 | 00850035498897 [Package] Package: Mixed Case [1 Units] In Commercial Distribution |
GS1 | 10850035498290 [Package] Contains: 00850035498293 Package: Case [12 Units] In Commercial Distribution |
QAI | Powered Microneedle Device |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-06-02 |
Device Publish Date | 2022-05-25 |
00850035498873 - SkinPen Precision Premium Treatment Kit | 2023-08-08 Treatment kit which includes a sterile, disposable cartridge tip, a hydrogel, and a disposable sleeve. |
00850035498286 - SP MicroPen EVO | 2022-06-02 MicroPen EVO Microneedling Device |
10850035498290 - SP MicroPen EVO Microneedling Cartridge | 2022-06-02MicroPen EVO Turbo Safety Cartridge (each). Cartridges are sterilized and packaged individually for single patient use. |
10850035498290 - SP MicroPen EVO Microneedling Cartridge | 2022-06-02 MicroPen EVO Turbo Safety Cartridge (each). Cartridges are sterilized and packaged individually for single patient use. |
00850035498392 - Progen PRP Advantage | 2022-05-17 15 mL Blood Draw Kit - Single |
00850035498408 - Progen PRP Advantage | 2022-05-17 30 ml Blood Draw Kits |
00850035498415 - Progen PRP Advantage | 2022-05-02 Progen PRP Advantage Kits - 15 ml PRP Tubes and Blood Draw Kit |
00850035498422 - Progen PRP Advantage | 2022-05-02 Progen PRP Advantage Kits - 30 ml PRP Tubes and Blood Draw Kit |
00850035498439 - Progen PRP Advantage | 2022-05-02 Progen PRP Advantage Kits - 15 ml PRP tubes and Blood Draw Kit |