Primary Device ID | 00810112921618 |
NIH Device Record Key | 91bd8cc7-f5d0-44db-8e16-feaeaa0802d5 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Primus Bone Level Fixture Surgical Mini KIT |
Version Model Number | PBSM |
Company DUNS | 101803383 |
Company Name | Inosys, Inc. |
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 | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00810112921618 [Primary] |
EIL | Gauge, Depth, Instrument, Dental |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00810112921618]
Moist Heat or Steam Sterilization
[00810112921618]
Moist Heat or Steam Sterilization
[00810112921618]
Moist Heat or Steam Sterilization
[00810112921618]
Moist Heat or Steam Sterilization
[00810112921618]
Moist Heat or Steam Sterilization
[00810112921618]
Moist Heat or Steam Sterilization
[00810112921618]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-06-23 |
Device Publish Date | 2022-06-15 |
00810112921571 - Fixture Lab Analog | 2022-06-27 Biotem AR FIXTURE LAB ANALOG 3.4Ø(aqua) |
00810112921588 - Fixture Lab Analog | 2022-06-27 Biotem AR FIXTURE LAB ANALOG 3.7Ø(Regular) |
00810112921595 - Fixture Lab Analog | 2022-06-27 Biotem AR FIXTURE LAB ANALOG 4.0Ø, 4.5Ø, 5.0Ø |
00810112921120 - PRIMUS Implant System | 2022-06-23 Biotem AR CEMENTED ABUTMENT(NON-HEX) 4.5Ø X 5.5mm(Cuff:5) |
00810112921137 - PRIMUS Implant System | 2022-06-23 Biotem AR CEMENTED ABUTMENT(NON-HEX) 4.5Ø X 5.5mm(Cuff:6) |
00810112921144 - PRIMUS Implant System | 2022-06-23 Biotem AR CEMENTED ABUTMENT(NON-HEX) 4.5Ø X 7.0mm(Cuff:1) |
00810112921151 - PRIMUS Implant System | 2022-06-23 Biotem AR CEMENTED ABUTMENT(NON-HEX) 4.5Ø X 7.0mm(Cuff:2) |
00810112921168 - PRIMUS Implant System | 2022-06-23 Biotem AR CEMENTED ABUTMENT(NON-HEX) 4.5Ø X 7.0mm(Cuff:3) |