Primary Device ID | 06009544001003 |
NIH Device Record Key | 9090d5af-b418-4779-86f5-b5e17070969f |
Commercial Distribution Status | In Commercial Distribution |
Version Model Number | BA6 |
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 | 06009544001003 [Primary] |
DZE | Implant, Endosseous, Root-Form |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-02-11 |
Device Publish Date | 2019-01-11 |
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06009544037620 - NA | 2024-04-12 Handpiece Insertion Tool for Ø5.0 Tri-Nex, Guided Surgery |
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06009544044796 - N/A | 2024-04-10 Implant DC, Ø4.0 x 11mm |
06009544039587 - N/A | 2024-04-03 Implant DC, Ø4.0 x 22mm |
06009544039594 - N/A | 2024-04-03 Implant DC, Ø4.0 x 24mm |
06009544046479 - N/A | 2024-04-01 Angulated Screw Channel Abutment, Engaging, for SP1 |