| Primary Device ID | 07613327291520 |
| NIH Device Record Key | 7381bda1-63b0-4ce2-a48f-94cbbc792cf5 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 5450800038 |
| Catalog Number | 5450800038 |
| Company DUNS | 690682147 |
| Company Name | STRYER MEDTEC K.K. |
| 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 | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07613327291520 [Primary] |
| MDM | INSTRUMENT, MANUAL, SURGICAL, GENERAL USE |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07613327291520]
Moist Heat or Steam Sterilization
[07613327291520]
Moist Heat or Steam Sterilization
[07613327291520]
Moist Heat or Steam Sterilization
[07613327291520]
Moist Heat or Steam Sterilization
[07613327291520]
Moist Heat or Steam Sterilization
[07613327291520]
Moist Heat or Steam Sterilization
[07613327291520]
Moist Heat or Steam Sterilization
[07613327291520]
Moist Heat or Steam Sterilization
[07613327291520]
Moist Heat or Steam Sterilization
[07613327291520]
Moist Heat or Steam Sterilization
[07613327291520]
Moist Heat or Steam Sterilization
[07613327291520]
Moist Heat or Steam Sterilization
[07613327291520]
Moist Heat or Steam Sterilization
[07613327291520]
Moist Heat or Steam Sterilization
[07613327291520]
Moist Heat or Steam Sterilization
[07613327291520]
Moist Heat or Steam Sterilization
[07613327291520]
Moist Heat or Steam Sterilization
[07613327291520]
Moist Heat or Steam Sterilization
[07613327291520]
Moist Heat or Steam Sterilization
[07613327291520]
Moist Heat or Steam Sterilization
[07613327291520]
Moist Heat or Steam Sterilization
[07613327291520]
Moist Heat or Steam Sterilization
[07613327291520]
Moist Heat or Steam Sterilization
[07613327291520]
Moist Heat or Steam Sterilization
[07613327291520]
Moist Heat or Steam Sterilization
[07613327291520]
Moist Heat or Steam Sterilization
[07613327291520]
Moist Heat or Steam Sterilization
[07613327291520]
Moist Heat or Steam Sterilization
[07613327291520]
Moist Heat or Steam Sterilization
[07613327291520]
Moist Heat or Steam Sterilization
[07613327291520]
Moist Heat or Steam Sterilization
[07613327291520]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-10-25 |
| Device Publish Date | 2018-09-24 |
| 07613327291827 - NA | 2020-01-06 Hyper Small Angled Handpiece without Tip, 25 kHz |
| 07613327291957 - Hyper LT | 2020-01-06 Hard Tissue Curette Handpiece without Tip, 25 kHz |
| 07613327289893 - Hyper LT | 2018-10-25 Angled Hard Tissue Curette Handpiece without Tip, 25 kHz |
| 07613327291483 - NA | 2018-10-25 Torque Wrench, 1.96 Nm - 7 mm |
| 07613327291490 - NA | 2018-10-25 Wrench, 10 mm |
| 07613327291513 - NA | 2018-10-25 Step Torque Wrench, 7 mm |
| 07613327291520 - NA | 2018-10-25Step Torque Wrench, Offset, 7 mm |
| 07613327291520 - NA | 2018-10-25 Step Torque Wrench, Offset, 7 mm |
| 07613327291537 - NA | 2018-10-25 Cleaning Wire |