Primary Device ID | 00850065741574 |
NIH Device Record Key | ba158555-676f-4cc6-af1f-35ecbea8603c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Trial 8mm |
Version Model Number | CSE06-R-1800-34 |
Company DUNS | 836975784 |
Company Name | CAPTIVA SPINE, 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 | false |
OTC Over-The-Counter | false |
Phone | 561-277-9480 |
info@captivaspine.com | |
Phone | 561-277-9480 |
info@captivaspine.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00850065741574 [Primary] |
LXH | Orthopedic Manual Surgical Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00850065741574]
Moist Heat or Steam Sterilization
[00850065741574]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-08-27 |
Device Publish Date | 2025-08-19 |
00850065741567 - Trial 7mm | 2025-08-27 7mm Trial |
00850065741574 - Trial 8mm | 2025-08-278mm Trial |
00850065741574 - Trial 8mm | 2025-08-27 8mm Trial |
00850065741581 - Trial 9mm | 2025-08-27 9mm Trial |
00850065741598 - Trial 10mm | 2025-08-27 10mm Trial |
00850065741604 - Trial 11mm | 2025-08-27 11mm Trial |
00850065741611 - Trial 12mm | 2025-08-27 12mm Trial |
00850065741628 - Distraction Paddle - 7mm | 2025-08-27 Distraction Paddle - 7mm |
00850065741635 - Distraction Paddle - 8mm | 2025-08-27 Distraction Paddle - 8mm |