Primary Device ID | 00840019935791 |
NIH Device Record Key | f015c6db-0dd0-4078-8b13-14cd4e0c58a3 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Cannulated Implant Kit: Std: 5.5 - 7.5 Ply (Cr) |
Version Model Number | 39-BK-1705 |
Catalog Number | 39-BK-1705 |
Company DUNS | 079398589 |
Company Name | PRECISION SPINE, INC. |
Device Count | 1 |
DM Exempt | true |
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 | false |
Lot Batch | false |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00840019935791 [Primary] |
MNI | Orthosis, Spinal Pedicle Fixation |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00840019935791]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-09-11 |
Device Publish Date | 2019-09-03 |
00840019960403 - ShurFit Lumbar Interbody | 2024-04-23 Curved Cage Implant Inserter |
00840019930932 - Reform POCT System | 2024-04-17 Ø3.5 x 34mm Polyaxial Screw - M/L Bias |
00840019930949 - Reform POCT System | 2024-04-17 Ø3.5 x 36mm Polyaxial Screw - M/L Bias |
00840019930956 - Reform POCT System | 2024-04-17 Ø3.5 x 38mm Polyaxial Screw - M/L Bias |
00840019930963 - Reform POCT System | 2024-04-17 Ø4.0 x 32mm Polyaxial Screw - M/L Bias |
00840019930970 - Reform POCT System | 2024-04-17 Ø4.0 x 34mm Polyaxial Screw - M/L Bias |
00840019930987 - Reform POCT System | 2024-04-17 Ø4.0 x 36mm Polyaxial Screw - M/L Bias |
00840019930994 - Reform POCT System | 2024-04-17 Ø4.0 x 38mm Polyaxial Screw - M/L Bias |