Primary Device ID | D785GS50R80 |
NIH Device Record Key | 739da5b4-701c-47ff-b124-e077c208c766 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Guided Surgery Ratchet |
Version Model Number | 5.0 Guided Surgery Ratchet |
Catalog Number | GS5.0 R8 |
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 | D785GS50R80 [Primary] |
NDP | Accessories, Implant, Dental, Endosseous |
Steralize Prior To Use | true |
Device Is Sterile | false |
[D785GS50R80]
Moist Heat or Steam Sterilization
[D785GS50R80]
Moist Heat or Steam Sterilization
[D785GS50R80]
Moist Heat or Steam Sterilization
[D785GS50R80]
Moist Heat or Steam Sterilization
[D785GS50R80]
Moist Heat or Steam Sterilization
[D785GS50R80]
Moist Heat or Steam Sterilization
[D785GS50R80]
Moist Heat or Steam Sterilization
[D785GS50R80]
Moist Heat or Steam Sterilization
[D785GS50R80]
Moist Heat or Steam Sterilization
[D785GS50R80]
Moist Heat or Steam Sterilization
[D785GS50R80]
Moist Heat or Steam Sterilization
[D785GS50R80]
Moist Heat or Steam Sterilization
[D785GS50R80]
Moist Heat or Steam Sterilization
[D785GS50R80]
Moist Heat or Steam Sterilization
[D785GS50R80]
Moist Heat or Steam Sterilization
[D785GS50R80]
Moist Heat or Steam Sterilization
[D785GS50R80]
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 |
D785GS50R90 | 5.0 Guided Surgery Ratchet 9mm Length |
D785GS50R80 | 5.0 Guided Surgery Ratchet 8mm Length |
D785GS50R100 | 5.0 Guided Surgery Ratchet 10mm Length |
D785GS40R90 | 4.0 Guided Surgery Ratchet 9mm Length |
D785GS40R80 | 4.0 Guided Surgery Ratchet 8mm Length |
D785GS40R100 | 4.0 Guided Surgery Ratchet 10mm Length |
D785GS325R90 | 3.25 Guided Surgery Ratchet 9mm Length |
D785GS325R100 | 3.25 Guided Surgery Ratchet 10mm Length |