Primary Device ID | 06009544025269 |
NIH Device Record Key | 45409e6c-1664-442a-a5c8-a141f6b7ec8b |
Commercial Distribution Status | In Commercial Distribution |
Version Model Number | PKC-EL-60-2 |
Company DUNS | 636239584 |
Company Name | SOUTHERN IMPLANTS (PTY) LTD |
Device Count | 1 |
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 | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
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 |
---|---|
GS1 | 06009544025269 [Primary] |
NHA | Abutment, Implant, Dental, Endosseous |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2019-11-08 |
Device Publish Date | 2019-01-09 |
06009544040941 - N/A | 2024-05-20 Abutment Peek Temp Eng ø3.0 DC |
06009544040958 - N/A | 2024-05-20 Abutment Peek Temp NE ø3.0 DC |
06009544040965 - N/A | 2024-05-20 Abutment Peek Temp Eng ø4.0 DC |
06009544040972 - N/A | 2024-05-20 Abutment Peek Temp NE ø3.5/4.0 DC |
06009544040989 - N/A | 2024-05-20 Abutment Peek Temp Eng ø5.0 DC |
06009544040996 - N/A | 2024-05-20 Abutment Peek Temp NE ø5.0 DC |
06009544041009 - N/A | 2024-05-20 Abutment Peek Temp Eng ø3.5 TN |
06009544041016 - N/A | 2024-05-20 Abutment Peek Temp NE ø3.5 TN |