Primary Device ID | 06009544003793 |
NIH Device Record Key | 6f96d697-36ee-4395-a6fa-120e2146ed3b |
Commercial Distribution Status | In Commercial Distribution |
Version Model Number | D-514T |
Company DUNS | 636239584 |
Company Name | SOUTHERN IMPLANTS (PTY) LTD |
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 | false |
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 | 06009544003793 [Primary] |
NDP | Accessories, Implant, Dental, Endosseous |
Steralize Prior To Use | false |
Device Is Sterile | true |
[06009544003793]
Moist Heat or Steam Sterilization
[06009544003793]
Moist Heat or Steam Sterilization
[06009544003793]
Moist Heat or Steam Sterilization
[06009544003793]
Moist Heat or Steam Sterilization
[06009544003793]
Moist Heat or Steam Sterilization
[06009544003793]
Moist Heat or Steam Sterilization
[06009544003793]
Moist Heat or Steam Sterilization
[06009544003793]
Moist Heat or Steam Sterilization
[06009544003793]
Moist Heat or Steam Sterilization
[06009544003793]
Moist Heat or Steam Sterilization
[06009544003793]
Moist Heat or Steam Sterilization
[06009544003793]
Moist Heat or Steam Sterilization
[06009544003793]
Moist Heat or Steam Sterilization
[06009544003793]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2020-01-09 |
Device Publish Date | 2018-11-21 |
06009544048589 - N/A | 2024-09-03 Implant SP1 Ø4.0x10mm |
06009544048596 - N/A | 2024-09-03 Implant SP1 Ø4.0x11mm |
06009544048619 - N/A | 2024-09-03 Implant SP1 Ø4.0x15mm |
06009544048626 - N/A | 2024-09-03 Implant SP1 Ø4.0x18mm |
06009544048633 - N/A | 2024-09-03 Implant SP1 Ø4.0x20mm |
06009544048640 - N/A | 2024-09-03 Implant SP1 Ø4.0x22mm |
06009544048657 - N/A | 2024-09-03 Implant SP1 Ø4.0x24mm |
06009544039785 - N/A | 2024-08-30 Cortical Perforator Drill for Guided Surgery ø4.1 |