| Primary Device ID | 00810633021491 |
| NIH Device Record Key | 3a45d1de-1cee-46cf-a574-8bd2e30a0b31 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HammerLock2 |
| Version Model Number | HL2SA |
| Company DUNS | 792619009 |
| Company Name | Biomedical Enterprises, Inc. |
| 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 | true |
| 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 |
| Phone | 210-881-0043 |
| gupton@bme-tx.com | |
| Phone | 210-881-0043 |
| gupton@bme-tx.com | |
| Phone | 1-800-255-2500 |
| xx@xx.xx | |
| Phone | 1-800-255-2500 |
| xx@xx.xx | |
| Phone | 1-800-255-2500 |
| xx@xx.xx | |
| Phone | 1-800-255-2500 |
| xx@xx.xx | |
| Phone | 1-800-255-2500 |
| xx@xx.xx | |
| Phone | 1-800-255-2500 |
| xx@xx.xx | |
| Phone | 1-800-255-2500 |
| xx@xx.xx | |
| Phone | 1-800-255-2500 |
| xx@xx.xx | |
| Phone | 1-800-255-2500 |
| xx@xx.xx | |
| Phone | 1-800-255-2500 |
| xx@xx.xx | |
| Phone | 1-800-255-2500 |
| xx@xx.xx | |
| Phone | 1-800-255-2500 |
| xx@xx.xx | |
| Phone | 1-800-255-2500 |
| xx@xx.xx | |
| Phone | 1-800-255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx |
| Length | 5 Millimeter |
| Length | 5 Millimeter |
| Length | 5 Millimeter |
| Length | 5 Millimeter |
| Length | 5 Millimeter |
| Length | 5 Millimeter |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored at room temperature |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810633021491 [Primary] |
| HTY | Pin, Fixation, Smooth |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-05-07 |
| Device Publish Date | 2015-10-24 |
| 00810633021507 | Drill Kit for BME HammerLock2 System |
| 00810633021491 | HammerLock2 12mm Proximal – 5mm Distal Implant, Angled |
| 00810633021484 | HammerLock2 12mm Proximal – 5mm Distal Implant |
| 00810633021477 | HammerLock2 15mm Proximal – 5mm Distal Implant, Angled |
| 00810633021460 | HammerLock2 15mm Proximal – 5mm Distal Implant |
| 00810633021453 | HammerLock2 15mm Proximal – 7mm Distal Implant, Angled |
| 00810633021446 | Hammerlock X-Type LargeHammerLock2 15mm Proximal – 7mm Distal Implant |