Primary Device ID | 00843193114945 |
NIH Device Record Key | 5d3e9ba2-4ad5-49b6-99c4-25049e4ae36f |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Prodisc L |
Version Model Number | PDL-L-IP08S |
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 | 00843193114945 [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 | 2023-12-18 |
Device Publish Date | 2023-12-08 |
10705034700182 | SUPERIOR END PLATE MEDIUM 11°-STERILE |
10705034700175 | SUPERIOR END PLATE MEDIUM 6°-STERILE |
10705034700151 | POLYETHYLENE INLAY W/TANTALUM MARKER/MEDIUM-14MM-STERILE |
10705034700144 | POLYETHYLENE INLAY W/TANTALUM MARKER/MEDIUM-12MM-STERILE |
10705034700137 | POLYETHYLENE INLAY W/TANTALUM MARKER/MEDIUM-10MM-STERILE |
10705034700106 | INFERIOR END PLATE MEDIUM-STERILE |
10705034700090 | SUPERIOR END PLATE LARGE 11°-STERILE |
10705034700083 | SUPERIOR END PLATE LARGE 6°-STERILE |
10705034700069 | POLYETHYLENE INLAY W/TANTALUM MARKER/LARGE-14MM-STERILE |
10705034700052 | POLYETHYLENE INLAY W/TANTALUM MARKER/LARGE-12MM-STERILE |
10705034700045 | POLYETHYLENE INLAY W/TANTALUM MARKER/LARGE-10MM-STERILE |
00843193114983 | SUPERIOR ENDPLATE MEDIUM 3°-STERILE |
00843193114976 | INFERIOR ENDPLATE MEDIUM 8°-STERILE |
00843193114969 | INFERIOR ENDPLATE MEDIUM 3°-STERILE |
00843193114952 | SUPERIOR ENDPLATE LARGE 3° -STERILE |
00843193114945 | INFERIOR ENDPLATE LARGE 8°-STERILE |
00843193114938 | INFERIOR ENDPLATE LARGE 3°-STERILE |
00843193111692 | INFERIOR END PLATE LARGE-STERILE |