Primary Device ID | 20705034462469 |
NIH Device Record Key | ca14ea76-1f9b-4dee-a4b5-f2e382534a37 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | CONFIDENCE SPINAL CEMENT SYSTEM |
Version Model Number | 283999001 |
Catalog Number | 283999001 |
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 | 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 |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx |
Handling Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Handling Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Handling Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Handling Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Handling Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Handling Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Handling Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Handling Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Handling Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Handling Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Handling Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Handling Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Handling Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Handling Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Handling Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10705034462462 [Primary] |
GS1 | 20705034462469 [Package] Contains: 10705034462462 Package: PACKAGE [10 Units] In Commercial Distribution |
LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2023-05-03 |
Device Publish Date | 2016-12-31 |
10705034209463 | CONFIDENCE SPINAL CEMENT SYSTEM INTRODUCER NEEDLE, DIAMOND TIP 13G x 4 Inches |
20705034462469 | CONFIDENCE SPINAL CEMENT SYSTEM CONFIDENCE NEEDLE ADAPTER |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CONFIDENCE SPINAL CEMENT SYSTEM 77416261 3613535 Live/Registered |
DePuy Synthes, Inc. 2008-03-07 |