| Primary Device ID | 00810112921502 |
| NIH Device Record Key | ac3f64d9-d8f8-4466-8680-b59d2b054755 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Transfer Impression Coping |
| Version Model Number | PBIT R50SH |
| 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 | 00810112921502 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810112921502]
Moist Heat or Steam Sterilization
[00810112921502]
Moist Heat or Steam Sterilization
[00810112921502]
Moist Heat or Steam Sterilization
[00810112921502]
Moist Heat or Steam Sterilization
[00810112921502]
Moist Heat or Steam Sterilization
[00810112921502]
Moist Heat or Steam Sterilization
[00810112921502]
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 |