Primary Device ID | M739FCP12130 |
NIH Device Record Key | 5976e40c-5ee6-44b2-89a8-b8b0264a4325 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Parallel Cage, 12 x 13mm |
Version Model Number | FCP1213 |
Company DUNS | 836975784 |
Company Name | CAPTIVA SPINE, INC. |
Device Count | 1 |
DM Exempt | false |
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 | 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 |
Device Issuing Agency | Device ID |
---|---|
HIBCC | M739FCP12130 [Primary] |
ODP | Intervertebral Fusion Device With Bone Graft, Cervical |
Steralize Prior To Use | true |
Device Is Sterile | false |
[M739FCP12130]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2020-02-24 |
Device Publish Date | 2015-08-28 |
M739102900109 - TransFasten - LSF, General Instrument Tray | 2024-05-03 Sterilization Case - General Instrument Tray |
M73910290020 - TransFasten - LSF, Quick Connect Drill | 2024-05-03 Quick Connect Drill |
M73910290030 - TransFasten-LSF, Tissue Protector | 2024-05-03 Tissue Protector |
M73910290050 - TransFasten-LSF, Implant Driver Shaft | 2024-05-03 Implant Driver Shaft |
M73910290060 - TransFasten-LSF, Offset Guide | 2024-05-03 Offset Guide |
M73910290070 - TransFasten-LSF, Tissue Dilator | 2024-05-03 Tissue Dilator |
M739102901009 - TransFasten-LSF, Plunger Rod | 2024-05-03 Plunger Rod |
M73910290110 - TransFasten - LSF, Implant Filling Tube | 2024-05-03 Implant Filling Tube |