| Primary Device ID | 04546540356581 |
| NIH Device Record Key | 18a789d5-0a3a-4199-a0d4-5df1934bf3c7 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 62-00148 |
| Catalog Number | 62-00148 |
| Company DUNS | 316153956 |
| Company Name | Stryker Leibinger GmbH & Co. KG |
| 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 | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04546540356581 [Primary] |
| HTW | BIT, DRILL |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04546540356581]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-04-06 |
| Device Publish Date | 2016-12-08 |
| 07613327579840 - N/A | 2025-09-16 Hybrid Tip Pointer |
| 07613327680522 - NA | 2025-08-08 Locking plate |
| 07613327651461 - NA | 2025-07-17 Burr hole cover with tab |
| 07613327504385 - NA | 2025-03-06 PEDIATRIC MANDIBULAR DISTRACTOR 2 |
| 07613327504392 - NA | 2025-03-06 PEDIATRIC MANDIBULAR DISTRACTOR 2 |
| 07613327353563 - NA | 2025-02-27 NAVIGATED DRILL GUIDE SET CONTAINER |
| 07613252196259 - FLUOROMAP | 2025-02-05 FLUOROMAP 1.0 - SALES DEMO CD |
| 07613252286578 - FLUOROMAP | 2025-02-05 FLUOROMAP 1.0 SOFTWARE |