Primary Device ID | 10705034341798 |
NIH Device Record Key | 9770341f-fc74-4388-afe7-9ce0a2b0d3f5 |
Commercial Distribution Discontinuation | 2018-12-31 |
Commercial Distribution Status | Not in Commercial Distribution |
Version Model Number | SPB400 |
Catalog Number | SPB400 |
Company DUNS | 107105876 |
Company Name | DEPUY SPINE, LLC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
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 |
Phone | +1(800)255-2500 |
xx@xx.xx |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10705034341798 [Primary] |
JEB | TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, MANUAL |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 5 |
Public Version Date | 2020-03-23 |
Device Publish Date | 2016-12-31 |
10705034003252 - ISOLA | 2024-04-05 ISOLA SPINE SYSTEM SPINAL WIRE WITH BUTTON 177.8mm |
10705034003269 - ISOLA | 2024-04-03 ISOLA SPINE SYSTEM DOUBLE WIRE 304.8mm |
10705034003276 - ISOLA | 2024-04-03 ISOLA SPINE SYSTEM BEADED WIRE 304.8mm |
10705034202952 - EXPEDIUM | 2024-04-03 EXPEDIUM SPINE SYSTEM WIRE CUTTER |
10705034302300 - EXPEDIUM | 2024-04-03 EXPEDIUM SPINE SYSTEM SMALL WIRE CUTTER |
10705034314716 - NA | 2024-04-03 MODIFIED INSTRUMENT ILIAC CUTTER ASSEMBLY 7.25mm |
10705034484044 - NA | 2024-04-03 MODIFIED INSTRUMENT TREPHINE |
10705034492353 - NA | 2024-04-03 MODIFIED INSTRUMENT BONE HARVESTER |