Primary Device ID | D785LOK08840 |
NIH Device Record Key | 43c82c39-a8c0-41ee-804b-73eacc0e5427 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | LOK INSERT PACK |
Version Model Number | YELLOW SILICONE INSERT FOR OCO-LOK 1.3LB RETENTION |
Catalog Number | LOK 088-4 |
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 | D785LOK08840 [Primary] |
NDP | Accessories, Implant, Dental, Endosseous |
Steralize Prior To Use | true |
Device Is Sterile | false |
[D785LOK08840]
Moist Heat or Steam Sterilization
[D785LOK08840]
Moist Heat or Steam Sterilization
[D785LOK08840]
Moist Heat or Steam Sterilization
[D785LOK08840]
Moist Heat or Steam Sterilization
[D785LOK08840]
Moist Heat or Steam Sterilization
[D785LOK08840]
Moist Heat or Steam Sterilization
[D785LOK08840]
Moist Heat or Steam Sterilization
[D785LOK08840]
Moist Heat or Steam Sterilization
[D785LOK08840]
Moist Heat or Steam Sterilization
[D785LOK08840]
Moist Heat or Steam Sterilization
[D785LOK08840]
Moist Heat or Steam Sterilization
[D785LOK08840]
Moist Heat or Steam Sterilization
[D785LOK08840]
Moist Heat or Steam Sterilization
[D785LOK08840]
Moist Heat or Steam Sterilization
[D785LOK08840]
Moist Heat or Steam Sterilization
[D785LOK08840]
Moist Heat or Steam Sterilization
[D785LOK08840]
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 |
D785LOK08940 | VIOLET SILICONE INSERT FOR OCO-LOK 5.5LB RETENTION (4PK) |
D785LOK08840 | YELLOW SILICONE INSERT FOR OCO-LOK 1.3LB RETENTION (4PK) |
D785LOK08740 | PINK SILICONE INSERT FOR OCO-LOK 2.6 LB RETENTION (4PK) |
D785LOK08640 | TRANSPARENT CLEAR SILICONE INSERT 4 LB RETENTION (4PK) |