| Primary Device ID | 00841307130331 |
| NIH Device Record Key | 433e165c-b060-4c55-8a8c-82ffaca4211d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GPS® Internal Replacement Male (White) |
| Version Model Number | 1000-92W |
| Catalog Number | 1000-92W |
| Company DUNS | 868856969 |
| Company Name | IMPLANT DIRECT SYBRON MANUFACTURING LLC |
| Device Count | 4 |
| 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 | 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 |
| Phone | 1-888-649-6425 |
| customerservice@implantdirect.com | |
| Phone | 1-888-649-6425 |
| customerservice@implantdirect.com | |
| Phone | 1-888-649-6425 |
| customerservice@implantdirect.com | |
| Phone | 1-888-649-6425 |
| customerservice@implantdirect.com | |
| Phone | 1-888-649-6425 |
| customerservice@implantdirect.com | |
| Phone | 1-888-649-6425 |
| customerservice@implantdirect.com | |
| Phone | 1-888-649-6425 |
| customerservice@implantdirect.com | |
| Phone | 1-888-649-6425 |
| customerservice@implantdirect.com | |
| Phone | 1-888-649-6425 |
| customerservice@implantdirect.com | |
| Phone | 1-888-649-6425 |
| customerservice@implantdirect.com | |
| Phone | 1-888-649-6425 |
| customerservice@implantdirect.com | |
| Phone | 1-888-649-6425 |
| customerservice@implantdirect.com | |
| Phone | 1-888-649-6425 |
| customerservice@implantdirect.com | |
| Phone | 1-888-649-6425 |
| customerservice@implantdirect.com | |
| Phone | 1-888-649-6425 |
| customerservice@implantdirect.com | |
| Phone | 1-888-649-6425 |
| customerservice@implantdirect.com | |
| Phone | 1-888-649-6425 |
| customerservice@implantdirect.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841307130331 [Unit of Use] |
| GS1 | 10841307130338 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00841307130331]
Moist Heat or Steam Sterilization
[00841307130331]
Moist Heat or Steam Sterilization
[00841307130331]
Moist Heat or Steam Sterilization
[00841307130331]
Moist Heat or Steam Sterilization
[00841307130331]
Moist Heat or Steam Sterilization
[00841307130331]
Moist Heat or Steam Sterilization
[00841307130331]
Moist Heat or Steam Sterilization
[00841307130331]
Moist Heat or Steam Sterilization
[00841307130331]
Moist Heat or Steam Sterilization
[00841307130331]
Moist Heat or Steam Sterilization
[00841307130331]
Moist Heat or Steam Sterilization
[00841307130331]
Moist Heat or Steam Sterilization
[00841307130331]
Moist Heat or Steam Sterilization
[00841307130331]
Moist Heat or Steam Sterilization
[00841307130331]
Moist Heat or Steam Sterilization
[00841307130331]
Moist Heat or Steam Sterilization
[00841307130331]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-03-20 |
| Device Publish Date | 2024-03-12 |