Primary Device ID | H6681009227 |
NIH Device Record Key | c220185f-5aa9-4f6f-8a0d-afa4b7c87bf8 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Clearmet |
Version Model Number | 1009227 |
Catalog Number | 1009227 |
Company DUNS | 073503117 |
Company Name | Keystone Industries |
Device Count | 5 |
DM Exempt | false |
Pre-market Exempt | false |
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 | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(800)333-3131 |
tschwear@keystoneind.com |
Length | 77 Millimeter |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
Device Issuing Agency | Device ID |
---|---|
HIBCC | H6681009227 [Primary] |
HIBCC | H66810092270 [Unit of Use] |
EBI | RESIN, DENTURE, RELINING, REPAIRING, REBASING |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-09-15 |
H66810092291 | Clearmet Dental Appliance Extrusion Pellets, bulk bag |
H6681009227 | Medium Dental Device Extrusion Pellets |
H6681009225 | Small Dental Device Extrusion Pellets |