Primary Device ID | 10841307119166 |
NIH Device Record Key | d21b3595-587c-4260-a6a4-ef2087e0d2ea |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ScrewRedirect® Guide Pin |
Version Model Number | 5047-07 |
Catalog Number | 5047-07 |
Company DUNS | 868856969 |
Company Name | IMPLANT DIRECT SYBRON MANUFACTURING LLC |
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 | 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 | 1-888-649-6425 |
customerservice@implantdirect.com |
Device Size Text, specify | 0 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10841307119166 [Primary] |
NDP | Accessories, Implant, Dental, Endosseous |
Steralize Prior To Use | true |
Device Is Sterile | false |
[10841307119166]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2019-11-27 |
Device Publish Date | 2015-12-29 |
10841307119173 | 5057-07 |
10841307119166 | 5047-07 |
10841307119159 | 5037-07 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SCREWREDIRECT 77178947 3619924 Dead/Cancelled |
IMPLANT DIRECT SYBRON INTERNATIONAL LLC 2007-05-11 |