| Primary Device ID | 00817493021241 |
| NIH Device Record Key | 55f8643f-4c6a-413e-9148-9798c5c04ae7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hive-T IBFD |
| Version Model Number | 05-A-0001-4011 |
| Company DUNS | 080469093 |
| Company Name | HD LIFESCIENCES 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Height | 11 Millimeter |
| Width | 11 Millimeter |
| Length | 32 Millimeter |
| Height | 11 Millimeter |
| Width | 11 Millimeter |
| Length | 32 Millimeter |
| Height | 11 Millimeter |
| Width | 11 Millimeter |
| Length | 32 Millimeter |
| Height | 11 Millimeter |
| Width | 11 Millimeter |
| Length | 32 Millimeter |
| Height | 11 Millimeter |
| Width | 11 Millimeter |
| Length | 32 Millimeter |
| Height | 11 Millimeter |
| Width | 11 Millimeter |
| Length | 32 Millimeter |
| Height | 11 Millimeter |
| Width | 11 Millimeter |
| Length | 32 Millimeter |
| Height | 11 Millimeter |
| Width | 11 Millimeter |
| Length | 32 Millimeter |
| Height | 11 Millimeter |
| Width | 11 Millimeter |
| Length | 32 Millimeter |
| Height | 11 Millimeter |
| Width | 11 Millimeter |
| Length | 32 Millimeter |
| Height | 11 Millimeter |
| Width | 11 Millimeter |
| Length | 32 Millimeter |
| Height | 11 Millimeter |
| Width | 11 Millimeter |
| Length | 32 Millimeter |
| Height | 11 Millimeter |
| Width | 11 Millimeter |
| Length | 32 Millimeter |
| Height | 11 Millimeter |
| Width | 11 Millimeter |
| Length | 32 Millimeter |
| Height | 11 Millimeter |
| Width | 11 Millimeter |
| Length | 32 Millimeter |
| Height | 11 Millimeter |
| Width | 11 Millimeter |
| Length | 32 Millimeter |
| Height | 11 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817493021241 [Primary] |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-02-24 |
| Device Publish Date | 2019-06-01 |
| 00817493021456 | TLIF Hive-T Interbody Spacer, 9W, 26L, 13H, 18° |
| 00817493021432 | TLIF Hive-T Interbody Spacer, 9W, 26L, 11H, 18° |
| 00817493021401 | TLIF Hive-T Interbody Spacer, 9W, 26L, 13H, 13° |
| 00817493021388 | TLIF Hive-T Interbody Spacer, 9W, 26L, 11H, 13° |
| 00817493021289 | TLIF Hive-T Curved Interbody Spacer, 11W, 32L, 15H, 8° |
| 00817493021272 | TLIF Hive-T Curved Interbody Spacer, 11W, 32L, 14H, 8° |
| 00817493021265 | TLIF Hive-T Curved Interbody Spacer, 11W, 32L, 13H, 8° |
| 00817493021258 | TLIF Hive-T Curved Interbody Spacer, 11W, 32L, 12H, 8° |
| 00817493021241 | TLIF Hive-T Curved Interbody Spacer, 11W, 32L, 11H, 8° |
| 00817493021234 | TLIF Hive-T Curved Interbody Spacer, 11W, 32L, 10H, 8° |
| 00817493021227 | TLIF Hive-T Curved Interbody Spacer, 11W, 32L, 9H, 8° |
| 00817493021210 | TLIF Hive-T Curved Interbody Spacer, 11W, 32L, 8H, 8° |
| 00817493021203 | TLIF Hive-T Curved Interbody Spacer, 11W, 32L, 7H, 8° |
| 00817493021371 | 11W x 32L x 15H Curved TLIF Trial Assembly |
| 00817493021364 | 11W x 32L x 14H Curved TLIF Trial Assembly |
| 00817493021357 | 11W x 32L x 13H Curved TLIF Trial Assembly |
| 00817493021340 | 11W x 32L x 12H Curved TLIF Trial Assembly |
| 00817493021333 | 11W x 32L x 11H Curved TLIF Trial Assembly |
| 00817493021326 | 11W x 32L x 10H Curved TLIF Trial Assembly |
| 00817493021319 | 11W x 32L x 9H Curved TLIF Trial Assembly |
| 00817493021302 | 11W x 32L x 8H Curved TLIF Trial Assembly |
| 00817493021296 | 11W x 32L x 7H Curved TLIF Trial Assembly |