| Primary Device ID | 20853624005029 |
| NIH Device Record Key | 0a5d6ffe-2eac-4f31-b2f5-aef8e12dd575 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PenBlade Safety Scalpel |
| Version Model Number | #15 Blade |
| Catalog Number | PB-M-15 |
| Company DUNS | 017535668 |
| Company Name | ZIEN MEDICAL TECHNOLOGIES, INC. |
| Device Count | 10 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00853624005025 [Unit of Use] |
| GS1 | 10853624005022 [Primary] |
| GS1 | 20853624005029 [Package] Contains: 10853624005022 Package: Shipper [10 Units] In Commercial Distribution |
| GS1 | 30853624005026 [Package] Package: Overshipper [4 Units] In Commercial Distribution |
| GDX | Scalpel, One-Piece |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-09-29 |
| Device Publish Date | 2020-09-21 |
| 20853624005029 | The PenBlade Safety Scalpel is a scalpel which contains a mechanism to extend and retract a blad |
| 20853624005012 | The PenBlade Safety Scalpel is a scalpel which contains a mechanism to extend and retract a blad |
| 20853624005005 | The PenBlade Safety Scalpel is a scalpel which contains a mechanism to extend and retract a blad |