Primary Device ID | 00843193113887 |
NIH Device Record Key | 5900d658-81ad-4ae4-87e5-ff89c4d6951a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Prodisc C SK |
Version Model Number | PDSMD5 |
Company DUNS | 949024850 |
Company Name | Centinel Spine, Inc. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Conditional |
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 | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00843193113887 [Primary] |
MJO | Prosthesis, Intervertebral Disc |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-07-27 |
Device Publish Date | 2023-07-19 |
00843193114020 | Prodisc C SK, Extra Large Deep, 7mm |
00843193114013 | Prodisc C SK, Extra Large Deep, 6mm |
00843193114006 | Prodisc C SK, Extra Large Deep, 5mm |
00843193113993 | Prodisc C SK, Extra Large, 7mm |
00843193113986 | Prodisc C SK, Extra Large, 6mm |
00843193113979 | Prodisc C SK, Extra Large, 5mm |
00843193113962 | Prodisc C SK, Large Deep, 7mm |
00843193113955 | Prodisc C SK, Large Deep, 6mm |
00843193113948 | Prodisc C SK, Large Deep, 5mm |
00843193113931 | Prodisc C SK, Large, 7mm |
00843193113924 | Prodisc C SK, Large, 6mm |
00843193113917 | Prodisc C SK, Large, 5mm |
00843193113900 | Prodisc C SK, Medium Deep, 7mm |
00843193113894 | Prodisc C SK, Medium Deep, 6mm |
00843193113887 | Prodisc C SK, Medium Deep, 5mm |
00843193113870 | Prodisc C SK, Medium, 7mm |
00843193113863 | Prodisc C SK, Medium, 6mm |
00843193113856 | Prodisc C SK, Medium, 5mm |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PRODISC C SK 97822309 not registered Live/Pending |
Centinel Spine, LLC 2023-03-03 |