Primary Device ID | 00840019968904 |
NIH Device Record Key | df8462b8-eabe-4b21-a890-129fb03232f0 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Dakota ALIF System |
Version Model Number | 69-RS-0015 |
Catalog Number | 69-RS-0015 |
Company DUNS | 079398589 |
Company Name | PRECISION SPINE, INC. |
Device Count | 1 |
DM Exempt | true |
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 | true |
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 Issuing Agency | Device ID |
---|---|
GS1 | 00840019968904 [Primary] |
HTR | Rasp |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00840019968904]
Moist Heat or Steam Sterilization
[00840019968904]
Moist Heat or Steam Sterilization
[00840019968904]
Moist Heat or Steam Sterilization
[00840019968904]
Moist Heat or Steam Sterilization
[00840019968904]
Moist Heat or Steam Sterilization
[00840019968904]
Moist Heat or Steam Sterilization
[00840019968904]
Moist Heat or Steam Sterilization
[00840019968904]
Moist Heat or Steam Sterilization
[00840019968904]
Moist Heat or Steam Sterilization
[00840019968904]
Moist Heat or Steam Sterilization
[00840019968904]
Moist Heat or Steam Sterilization
[00840019968904]
Moist Heat or Steam Sterilization
[00840019968904]
Moist Heat or Steam Sterilization
[00840019968904]
Moist Heat or Steam Sterilization
[00840019968904]
Moist Heat or Steam Sterilization
[00840019968904]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-03-21 |
Device Publish Date | 2025-03-13 |
00840019968355 | Large Cage Insertion Tips Kit (39 & 42mm) |
00840019968348 | Large Cage Insertion Tips Caddy (39 & 42mm) |
00840019968300 | Disc Distractor Kit |
00840019968843 | Large Cage Implant Kit - 42 x 30mm x 25° & 30mm° |
00840019968836 | Large Cage Implant Caddy - 42 x 30mm x 25° & 30mm° |
00840019968829 | Large Cage Implant Kit - 42 x 30mm x 20° |
00840019968812 | Large Cage Implant Caddy - 42 x 30mm x 20° |
00840019968805 | Large Cage Implant Kit - 42 x 30mm x 15° |
00840019968799 | Large Cage Implant Caddy - 42 x 30mm x 15° |
00840019968782 | Large Cage Implant Kit - 42 x 30mm x 8° |
00840019968775 | Large Cage Implant Caddy - 42 x 30mm x 8° |
00840019968768 | Large Cage Implant Kit - 39 x 29mm x 25° & 30° |
00840019968751 | Large Cage Implant Caddy - 39 x 29mm x 25° & 30° |
00840019968744 | Large Cage Implant Kit - 39 x 29mm x 20° |
00840019968737 | Large Cage Implant Caddy - 39 x 29mm x 20° |
00840019968720 | Large Cage Implant Kit - 39 x 29mm x 15° |
00840019968713 | Large Cage Implant Caddy - 39 x 29mm x 15° |
00840019968706 | Large Cage Implant Kit - 39 x 29mm x 8° |
00840019968690 | Large Cage Implant Caddy - 39 x 29mm x 8° |
00840019968683 | Standard Cage Implant Kit - 36 x 28mm x 25° & 30° |
00840019968676 | Standard Cage Implant Caddy - 36 x 28mm x 25° & 30° |
00840019968669 | Standard Cage Implant Kit - 36 x 28mm x 20° |
00840019968652 | Standard Cage Implant Caddy - 36 x 28mm x 20° |
00840019968645 | Standard Cage Implant Kit - 36 x 28mm x 15° |
00840019968638 | Standard Cage Implant Caddy - 36 x 28mm x 15° |
00840019968621 | Standard Cage Implant Kit - 36 x 28mm x 8° |
00840019968614 | Standard Cage Implant Caddy - 36 x 28mm x 8° |
00840019968607 | Standard Cage Implant Kit - 33 x 27mm x 25° & 30° |
00840019968591 | Standard Cage Implant Caddy - 33 x 27mm x 25° & 30° |
00840019968584 | Standard Cage Implant Kit - 33 x 27mm x 20° |
00840019968577 | Standard Cage Implant Caddy - 33 x 27mm x 20° |
00840019968560 | Standard Cage Implant Kit - 33 x 27mm x 15° |
00840019968553 | Standard Cage Implant Caddy - 33 x 27mm x 15° |
00840019968546 | Standard Cage Implant Kit - 33 x 27mm x 8° |
00840019968539 | Standard Cage Implant Caddy - 33 x 27mm x 8° |
00840019968522 | Standard Cage Implant Kit - 30 x 26mm x 25° & 30° |
00840019968515 | Standard Cage Implant Caddy - 30 x 26mm x 25° & 30° |
00840019968508 | Standard Cage Implant Kit - 30 x 26mm x 20° |
00840019968492 | Standard Cage Implant Caddy - 30 x 26mm x 20° |
00840019968485 | Standard Cage Implant Kit - 30 x 26mm x 15° |
00840019968478 | Standard Cage Implant Caddy - 30 x 26mm x 15° |
00840019968461 | Standard Cage Implant Kit - 30 x 26mm x 8° |
00840019968454 | Standard Cage Implant Caddy - 30 x 26mm x 8° |
00840019968447 | Disc Distractor Tip Kit |
00840019968430 | Disc Distractor Tip Caddy |
00840019968423 | Standard Cage Insertion Tip Kit (30, 33, & 36mm) |
00840019968416 | Standard Cage Insertion Tip Caddy (30, 33, & 36mm) |
00840019969048 | 30 X 26 X 15mm X 20° Trial Rasp |
00840019969031 | 30 X 26 X 13mm X 20° Trial Rasp |
00840019969024 | 30 X 26 X 19mm X 15° Trial Rasp |