Primary Device ID | D785002CAPWORW0 |
NIH Device Record Key | f8024801-10aa-45de-8027-e0b5b2a3bd0b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | HOUSING CAP WITH ORING WHITE |
Version Model Number | 002 CAP WITH O-RING WHITE |
Catalog Number | 002 CAP W/O-RING (WHITE) |
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 | true |
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 | D785002CAPWORW0 [Primary] |
NDP | Accessories, Implant, Dental, Endosseous |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-03-20 |
Device Publish Date | 2024-03-12 |
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 |
D785002CAPWORED0 - HOUSING CAP WITH ORING RED | 2024-03-20 002 CAP WITH O-RING (RED) |
D785002CAPWORW0 - HOUSING CAP WITH ORING WHITE | 2024-03-20002 CAP WITH O-RING (WHITE) |
D785002CAPWORW0 - HOUSING CAP WITH ORING WHITE | 2024-03-20 002 CAP WITH O-RING (WHITE) |
D785003CAPWO0 - HOUSING CAP WITH BLK ORING | 2024-03-20 003 CAP WITH 003 BLK O-RING INSERTED |