Primary Device ID | 04546540903839 |
NIH Device Record Key | c93b9c2b-e589-4986-96c7-c1220cb5259b |
Commercial Distribution Status | In Commercial Distribution |
Version Model Number | 0400655000 |
Catalog Number | 0400655000 |
Company DUNS | 196548481 |
Company Name | STRYKER CORPORATION |
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 | true |
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)253-3210 |
Inst.Stryker.cs@Stryker.com |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Device Issuing Agency | Device ID |
---|---|
GS1 | 04546540903839 [Primary] |
FXZ | HELMET, SURGICAL |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2018-10-25 |
Device Publish Date | 2018-09-24 |
07613327141870 - SOLIS | 2024-06-28 SPECIALTY INSERTER WITH STOP |
07613327141924 - SOLIS | 2024-06-28 SPECIALTY AS INSERTER WITH STOP |
07613327261707 - OPUS | 2024-06-28 NUT WRENCH |
07613327261714 - OPUS | 2024-06-28 SCREWDRIVER |
07613327261721 - OPUS | 2024-06-28 ANTI-ROTATION WRENCH |
07613327265132 - XIA PRECISION SYSTEM | 2024-06-28 XIA CANNULATED ROUND HANDLE RATCHET |
07613327265170 - XIA PRECISION SYSTEM | 2024-06-28 XIA CANNULATED T-HANDLE NON-RATCHET |
07613327265217 - XIA PRECISION SYSTEM | 2024-06-28 XIA CANNULATED ROUND HANDLE NON-RATCHET |