Primary Device ID | B047CL1012080 |
NIH Device Record Key | b7db866e-8d71-4ce2-b3f8-1632505cc9d7 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SPINENET ACC® |
Version Model Number | CL101208 |
Company DUNS | 792052321 |
Company Name | SPINENET, LLC |
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 | B047CL1012080 [Primary] |
ODP | Intervertebral Fusion Device With Bone Graft, Cervical |
Steralize Prior To Use | true |
Device Is Sterile | false |
[B047CL1012080]
Moist Heat or Steam Sterilization
[B047CL1012080]
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 | 2015-10-05 |
B047CTL1214100 | Trial 12mmx14mmx10mm |
B047CTL1214090 | Trial 12mmx14mmx9mm |
B047CTL1214080 | Trial 12mmx14mmx8mm |
B047CTL1214070 | Trial 12mmx14mmx7mm |
B047CTL1214060 | Trial 12mmx14mmx6mm |
B047CTL1214050 | Trial 12mmx14mmx5mm |
B047CTL1012100 | Trial 10mmx12mmx10mm |
B047CTL1012090 | Trial 10mmx12mmx9mm |
B047CTL1012080 | Trial 10mmx12mmx8mm |
B047CTL1012070 | Trial 10mmx12mmx7mm |
B047CTL1012060 | Trial 10mmx12mmx6mm |
B047CTL1012050 | Trial 10mmx12mmx5mm |
B047CL1214100 | 12mmx14mmx10mm |
B047CL1214090 | 12mmx14mmx9mm |
B047CL1214080 | 12mmx14mmx8mm |
B047CL1214070 | 12mmx14mmx7mm |
B047CL1214060 | 12mmx14mmx6mm |
B047CL1214050 | 12mmx14mmx5mm |
B047CL1012100 | 10mmx12mmx10mm |
B047CL1012090 | 10mmx12mmx9mm |
B047CL1012080 | 10mmx12mmx8mm |
B047CL1012070 | 10mmx12mmx7mm |
B047CL1012060 | 10mmx12mmx6mm |