Primary Device ID | 00810112921540 |
NIH Device Record Key | c3d9d0d0-77a9-459e-a801-b983e1a44292 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Pick-Up Impression Coping |
Version Model Number | PBIP R45SH |
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 | 00810112921540 [Primary] |
NDP | Accessories, Implant, Dental, Endosseous |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00810112921540]
Moist Heat or Steam Sterilization
[00810112921540]
Moist Heat or Steam Sterilization
[00810112921540]
Moist Heat or Steam Sterilization
[00810112921540]
Moist Heat or Steam Sterilization
[00810112921540]
Moist Heat or Steam Sterilization
[00810112921540]
Moist Heat or Steam Sterilization
[00810112921540]
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 |
00810112921564 | Biotem AR PICK UP IMPRESSION COPING(HEX)5.5Ø X 10.0mm(Hex) |
00810112921557 | Biotem AR PICK UP IMPRESSION COPING(HEX)4.5Ø X 13.0mm(Hex) |
00810112921540 | Biotem AR PICK UP IMPRESSION COPING(HEX)4.5Ø X 10.0mm(Hex) |
00810112921533 | Biotem AR PICK UP IMPRESSION COPING(HEX)3.4Ø X 13.0mm(Hex) |
00810112921526 | Biotem AR PICK UP IMPRESSION COPING(HEX)3.4Ø X 10.0mm(Hex) |