Primary Device ID | D785GSP0 |
NIH Device Record Key | 4424f691-3fcd-44d3-a0e0-9df5343f1dfc |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Retention Pin |
Version Model Number | Guided Surgery Retention Pins |
Catalog Number | GS-P |
Company DUNS | 094146123 |
Company Name | OCO BIOMEDICAL INC |
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 | true |
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 Issuing Agency | Device ID |
---|---|
HIBCC | D785GSP0 [Primary] |
NDP | Accessories, Implant, Dental, Endosseous |
Steralize Prior To Use | true |
Device Is Sterile | false |
[D785GSP0]
Moist Heat or Steam Sterilization
[D785GSP0]
Moist Heat or Steam Sterilization
[D785GSP0]
Moist Heat or Steam Sterilization
[D785GSP0]
Moist Heat or Steam Sterilization
[D785GSP0]
Moist Heat or Steam Sterilization
[D785GSP0]
Moist Heat or Steam Sterilization
[D785GSP0]
Moist Heat or Steam Sterilization
[D785GSP0]
Moist Heat or Steam Sterilization
[D785GSP0]
Moist Heat or Steam Sterilization
[D785GSP0]
Moist Heat or Steam Sterilization
[D785GSP0]
Moist Heat or Steam Sterilization
[D785GSP0]
Moist Heat or Steam Sterilization
[D785GSP0]
Moist Heat or Steam Sterilization
[D785GSP0]
Moist Heat or Steam Sterilization
[D785GSP0]
Moist Heat or Steam Sterilization
[D785GSP0]
Moist Heat or Steam Sterilization
[D785GSP0]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-03-20 |
Device Publish Date | 2024-03-12 |
D785AS3100TSI0 - TSI/ERI Abutment Screw | 2024-05-07 TSI/ERI Abutment Screw 3.25mm |
D785AS4100TSI0 - TSI/ERI Abutment Screw | 2024-05-07 TSI/ERI Abutment Screw 4.0/5.0mm |
D78529SDIOBPK0 - 2.9 SDI O-BALL PROSTHETIC KIT | 2024-04-29 2.9MM SDI O-BALL PROSTHETIC KIT |
D78540TPKOB0 - TSI PROSTHETIC KIT | 2024-04-25 4.0MM TWO-STAGE O-BALL PROSTHETIC KIT |
D785325ICBPK0 - ISI C&B PROSTHETIC KIT | 2024-04-17 3.25MM ISI CROWN & BRIDGE PROSTHETIC KIT |
D785002ORKIT0 - O-RING PACK | 2024-04-11 002 O-Ring Kit |
D785003ORKIT0 - O-RING PACK | 2024-04-11 003 O-Ring Kit |
D785002CAPWO0 - HOUSING CAP WITH O-RING | 2024-03-20 002 CAP WITH 002 BLK O-RING INSERTED |