Primary Device ID | 00810112921595 |
NIH Device Record Key | 3e31e970-ee9c-4920-8ff4-7f8661195e9d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Fixture Lab Analog |
Version Model Number | PBFAN R40H |
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 | true |
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 | 00810112921595 [Primary] |
NDP | Accessories, Implant, Dental, Endosseous |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00810112921595]
Moist Heat or Steam Sterilization
[00810112921595]
Moist Heat or Steam Sterilization
[00810112921595]
Moist Heat or Steam Sterilization
[00810112921595]
Moist Heat or Steam Sterilization
[00810112921595]
Moist Heat or Steam Sterilization
[00810112921595]
Moist Heat or Steam Sterilization
[00810112921595]
Moist Heat or Steam Sterilization
[00810112921595]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-06-27 |
Device Publish Date | 2022-06-17 |
00810112921595 | Biotem AR FIXTURE LAB ANALOG 4.0Ø, 4.5Ø, 5.0Ø |
00810112921588 | Biotem AR FIXTURE LAB ANALOG 3.7Ø(Regular) |
00810112921571 | Biotem AR FIXTURE LAB ANALOG 3.4Ø(aqua) |