Primary Device ID | 00840311257928 |
NIH Device Record Key | c04a625a-73ca-4a2a-b7d8-46b86868eddf |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | STREAMLINE OCT |
Version Model Number | C999-000004 |
Company DUNS | 081224143 |
Company Name | Xtant Medical Holdings, Inc. |
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 |
Phone | 1-888-886-9354 |
CS@xtantmedical.com | |
Phone | 1-888-886-9354 |
CS@xtantmedical.com | |
Phone | 1-888-886-9354 |
CS@xtantmedical.com | |
Phone | 1-888-886-9354 |
CS@xtantmedical.com | |
Phone | 1-888-886-9354 |
CS@xtantmedical.com | |
Phone | 1-888-886-9354 |
CS@xtantmedical.com | |
Phone | 1-888-886-9354 |
CS@xtantmedical.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00840311257928 [Primary] |
FZT | Cutter, Surgical |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00840311257928]
Moist Heat or Steam Sterilization
[00840311257928]
Moist Heat or Steam Sterilization
[00840311257928]
Moist Heat or Steam Sterilization
[00840311257928]
Moist Heat or Steam Sterilization
[00840311257928]
Moist Heat or Steam Sterilization
[00840311257928]
Moist Heat or Steam Sterilization
[00840311257928]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-08-19 |
Device Publish Date | 2025-08-11 |
00840311257928 - STREAMLINE OCT | 2025-08-19HANDHELD RATCHETING ROD CUTTER |
00840311257928 - STREAMLINE OCT | 2025-08-19 HANDHELD RATCHETING ROD CUTTER |
00840311233168 - Contact ALP | 2025-08-15 Threaded Pin |
00840311257874 - Cortera Spinal Fixation System | 2025-07-15 Case, Half, 1LVL, R2R Connectors |
00840311257881 - Cortera Spinal Fixation System | 2025-07-15 Case, ASM, IMP, R2R Connectors |
00840311257898 - Cortera Spinal Fixation System | 2025-07-15 Cortera Rod-to-Rod Connectors BOM |
M697T08012001 - Irix-A Lumbar Integrated Fusion System | 2025-06-30 PLIERS INSERTER ASSEMBLY |
00810076562056 - CervAlign Anterior Cervical Plate System | 2025-06-12 Temporary Plate Holding Push Pin |
00810076562070 - CervAlign Anterior Cervical Plate System | 2025-06-12 Temporary Plate Holding Threaded Pin |