| Primary Device ID | 00853508002362 |
| NIH Device Record Key | e011b162-3134-42af-82b1-a9834d438a1c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Boston Endo Surgical Technologies LLC |
| Version Model Number | PK1015 |
| Catalog Number | PK1015 |
| Company DUNS | 958212029 |
| Company Name | LACEY MANUFACTURING COMPANY, 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Length | 7.69 Inch |
| Length | 7.69 Inch |
| Length | 7.69 Inch |
| Length | 7.69 Inch |
| Length | 7.69 Inch |
| Length | 7.69 Inch |
| Length | 7.69 Inch |
| Length | 7.69 Inch |
| Length | 7.69 Inch |
| Length | 7.69 Inch |
| Length | 7.69 Inch |
| Length | 7.69 Inch |
| Length | 7.69 Inch |
| Length | 7.69 Inch |
| Length | 7.69 Inch |
| Length | 7.69 Inch |
| Length | 7.69 Inch |
| Length | 7.69 Inch |
| Length | 7.69 Inch |
| Length | 7.69 Inch |
| Length | 7.69 Inch |
| Length | 7.69 Inch |
| Length | 7.69 Inch |
| Length | 7.69 Inch |
| Length | 7.69 Inch |
| Length | 7.69 Inch |
| Length | 7.69 Inch |
| Length | 7.69 Inch |
| Length | 7.69 Inch |
| Length | 7.69 Inch |
| Length | 7.69 Inch |
| Length | 7.69 Inch |
| Length | 7.69 Inch |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00853508002362 [Primary] |
| PDQ | Neurosurgical Nerve Locator |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-04-13 |
| Device Publish Date | 2021-04-05 |
| 00853508002546 | Bayonet Bipolar Forceps Straight Tip |
| 00853508002362 | Pedicle Access Needle- NIM Pedicle Probe Straight |
| 00853508002355 | Pedicle Access Needle- NIM Pedicle Probe Lumbar |
| 00853508002348 | Pedicle Access Needle- NIM Pedicle Probe Thoracic |
| 00853508002331 | Pedicle Access Needle- NIM NAV PAK Needle Trocar |
| 00853508002324 | Pedicle Access Needle- NAV PAK Needle Trocar |