| Primary Device ID | 07898915128352 |
| NIH Device Record Key | 4983a23d-9db4-4442-a8d2-dac608d6e229 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Skin Cooler Pen |
| Version Model Number | SCPBX01 |
| Company DUNS | 902645407 |
| Company Name | FABINJECT INDUSTRIA E COMERCIO IMPORTACAO E EXPORTACAO LTDA |
| 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 | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | +551236021415 |
| loja@fabinject.com.br | |
| Phone | +551236021415 |
| loja@fabinject.com.br | |
| Phone | +551236021415 |
| loja@fabinject.com.br | |
| Phone | +551236021415 |
| loja@fabinject.com.br | |
| Phone | +551236021415 |
| loja@fabinject.com.br | |
| Phone | +551236021415 |
| loja@fabinject.com.br | |
| Phone | +551236021415 |
| loja@fabinject.com.br | |
| Phone | +551236021415 |
| loja@fabinject.com.br | |
| Phone | +551236021415 |
| loja@fabinject.com.br | |
| Phone | +551236021415 |
| loja@fabinject.com.br | |
| Phone | +551236021415 |
| loja@fabinject.com.br | |
| Phone | +551236021415 |
| loja@fabinject.com.br | |
| Phone | +551236021415 |
| loja@fabinject.com.br | |
| Phone | +551236021415 |
| loja@fabinject.com.br | |
| Phone | +551236021415 |
| loja@fabinject.com.br | |
| Phone | +551236021415 |
| loja@fabinject.com.br | |
| Phone | +551236021415 |
| loja@fabinject.com.br |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07898915128352 [Primary] |
| IME | Pack, Hot Or Cold, Reusable |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2025-03-03 |
| Device Publish Date | 2024-06-13 |
| 00850064466355 | Local cooling device for therapeutic procedures. |
| 07898915128352 | Local cooling device for therapeutic procedures. |