Primary Device ID | M9935071810 |
NIH Device Record Key | 07f7f779-cdb2-4e61-bea2-84929247b399 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | GSO PCT Spinal System |
Version Model Number | 507181 |
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 | true |
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 |
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Device Issuing Agency | Device ID |
---|---|
HIBCC | M9935071810 [Primary] |
LRP | Tray, Surgical |
Steralize Prior To Use | true |
Device Is Sterile | false |
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
[M9935071810]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2020-10-21 |
Device Publish Date | 2018-09-21 |
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M9935071550 | Drill Guide |
M9935071810 | Instrument Case |
M9935071800 | Implant Instrument Case |
M9935071540 | Bone Awl Assembly |
M9935071600 | Bone Screw Tap |
M9935071590 | Bone Screw Tap |
M9935071580 | Bone Screw Tap |