Primary Device ID | M9935042440 |
NIH Device Record Key | 43d77d53-0413-41b8-9037-884ee717ae8a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | GSO GS1 Spacer System |
Version Model Number | 504244 |
Company DUNS | 028008203 |
Company Name | GOLD STANDARD ORTHOPEDICS, 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 | true |
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 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Issuing Agency | Device ID |
---|---|
HIBCC | M9935042440 [Primary] |
HWX | Tap, Bone |
Steralize Prior To Use | true |
Device Is Sterile | false |
[M9935042440]
Moist Heat or Steam Sterilization
[M9935042440]
Moist Heat or Steam Sterilization
[M9935042440]
Moist Heat or Steam Sterilization
[M9935042440]
Moist Heat or Steam Sterilization
[M9935042440]
Moist Heat or Steam Sterilization
[M9935042440]
Moist Heat or Steam Sterilization
[M9935042440]
Moist Heat or Steam Sterilization
[M9935042440]
Moist Heat or Steam Sterilization
[M9935042440]
Moist Heat or Steam Sterilization
[M9935042440]
Moist Heat or Steam Sterilization
[M9935042440]
Moist Heat or Steam Sterilization
[M9935042440]
Moist Heat or Steam Sterilization
[M9935042440]
Moist Heat or Steam Sterilization
[M9935042440]
Moist Heat or Steam Sterilization
[M9935042440]
Moist Heat or Steam Sterilization
[M9935042440]
Moist Heat or Steam Sterilization
[M9935042440]
Moist Heat or Steam Sterilization
[M9935042440]
Moist Heat or Steam Sterilization
[M9935042440]
Moist Heat or Steam Sterilization
[M9935042440]
Moist Heat or Steam Sterilization
[M9935042440]
Moist Heat or Steam Sterilization
[M9935042440]
Moist Heat or Steam Sterilization
[M9935042440]
Moist Heat or Steam Sterilization
[M9935042440]
Moist Heat or Steam Sterilization
[M9935042440]
Moist Heat or Steam Sterilization
[M9935042440]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2022-12-08 |
Device Publish Date | 2018-09-21 |
M9935042040 | Spacer Case |
M9935042440 | Bone Tap With 1/4" Square QC |
M9935042430 | Bone Tap With 1/4" Square QC |