Primary Device ID | 00840019908078 |
NIH Device Record Key | daf0f8b1-8ca6-40da-8a8b-9028f9ea2011 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ShurFit ACIF Systems |
Version Model Number | 45-CP-1010 |
Catalog Number | 45-CP-1010 |
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 | true |
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 | 00840019908078 [Primary] |
ODP | Intervertebral Fusion Device With Bone Graft, Cervical |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00840019908078]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2020-02-24 |
Device Publish Date | 2019-04-12 |
00840019908092 | 10° X 12mm Implant |
00840019908085 | 10° X 11mm Implant |
00840019908078 | 10° X 10mm Implant |
00840019908061 | 10° X 9mm Implant |
00840019908054 | 10° X 8mm Implant |
00840019908047 | 10° X 7mm Implant |
00840019908030 | 10° X 6mm Implant |
00840019908023 | 10° X 5mm Implant |
00840019908016 | 5° X 12mm Implant |
00840019908009 | 5° X 11mm Implant |
00840019907996 | 5° X 10mm Implant |
00840019907989 | 5° X 9mm Implant |
00840019907972 | 5° X 8mm Implant |
00840019907965 | 5° X 7mm Implant |
00840019907958 | 5° X 6mm Implant |
00840019907941 | 5° X 5mm Implant |
00840019936750 | Implant Kit |