Primary Device ID | 10850017962207 |
NIH Device Record Key | f4775e9f-293b-4eea-bef6-921c3b392e58 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | HA Coated S-Core Implant |
Version Model Number | 20-1000-01-P |
Company DUNS | 117417828 |
Company Name | SUBCHONDRAL SOLUTIONS, 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 | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Height | 10 Millimeter |
Length | 10 Millimeter |
Height | 10 Millimeter |
Length | 10 Millimeter |
Height | 10 Millimeter |
Length | 10 Millimeter |
Height | 10 Millimeter |
Length | 10 Millimeter |
Height | 10 Millimeter |
Length | 10 Millimeter |
Height | 10 Millimeter |
Length | 10 Millimeter |
Height | 10 Millimeter |
Length | 10 Millimeter |
Height | 10 Millimeter |
Length | 10 Millimeter |
Height | 10 Millimeter |
Length | 10 Millimeter |
Height | 10 Millimeter |
Length | 10 Millimeter |
Height | 10 Millimeter |
Length | 10 Millimeter |
Height | 10 Millimeter |
Length | 10 Millimeter |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00850017962200 [Primary] |
GS1 | 10850017962207 [Package] Contains: 00850017962200 Package: Case [10 Units] In Commercial Distribution |
HWC | Screw, Fixation, Bone |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-10-30 |
Device Publish Date | 2020-10-22 |
10850017962207 | HA Coated 10 mm x 10 mm S-Core Implant |
10850017962191 | HA Coated 9 mm x 9.5 mm S-Core Implant |
10850017962184 | HA Coated 8 mm x 9 mm S-Core Implant |
10850017962177 | HA Coated 7 mm x 8.5 mm S-Core Implant |
10850017962160 | HA Coated 6 mm x 8 mm S-Core Implant |
10850017962153 | HA Coated 5 mm x 7.5 mm S-Core Implant |
10850017962146 | HA Coated 4 mm x 7 mm S-Core Implant |