Primary Device ID | 00810112921519 |
NIH Device Record Key | 534055fb-b2a9-41f7-8742-15723cc33655 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Transfer Impression Coping |
Version Model Number | PBIT R50LH |
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 | 00810112921519 [Primary] |
NDP | Accessories, Implant, Dental, Endosseous |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00810112921519]
Moist Heat or Steam Sterilization
[00810112921519]
Moist Heat or Steam Sterilization
[00810112921519]
Moist Heat or Steam Sterilization
[00810112921519]
Moist Heat or Steam Sterilization
[00810112921519]
Moist Heat or Steam Sterilization
[00810112921519]
Moist Heat or Steam Sterilization
[00810112921519]
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 |
00810112921519 | Biotem AR TRANSFER IMPRESSION COPING(HEX) Ø5.0-14mm for standard |
00810112921502 | Biotem AR TRANSFER IMPRESSION COPING(HEX) Ø5.0-11mm for standard |
00810112921496 | Biotem AR TRANSFER IMPRESSION COPING(HEX) Ø4.0-14mm for standard |
00810112921489 | Biotem AR TRANSFER IMPRESSION COPING(HEX) Ø4.0-11mm for standard |
00810112921472 | Biotem AR TRANSFER IMPRESSION COPING(HEX) Ø4.0-14mm for mini |
00810112921465 | Biotem AR TRANSFER IMPRESSION COPING(HEX) Ø4.0-11mm for mini |