| Primary Device ID | 00810097802247 |
| NIH Device Record Key | 2415ca24-be70-4eff-8805-8c991b5fe999 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 10.1 Nm TORQUE LIMITER HANDLE |
| Version Model Number | 101-0002 |
| Catalog Number | 101-0002 |
| Company DUNS | 089645059 |
| Company Name | SMV SCIENTIFIC LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | 1-800-969-0639 |
| quality@osteocentric.com | |
| Phone | 1-800-969-0639 |
| quality@osteocentric.com | |
| Phone | 1-800-969-0639 |
| quality@osteocentric.com | |
| Phone | 1-800-969-0639 |
| quality@osteocentric.com | |
| Phone | 1-800-969-0639 |
| quality@osteocentric.com | |
| Phone | 1-800-969-0639 |
| quality@osteocentric.com | |
| Phone | 1-800-969-0639 |
| quality@osteocentric.com | |
| Phone | 1-800-969-0639 |
| quality@osteocentric.com | |
| Phone | 1-800-969-0639 |
| quality@osteocentric.com | |
| Phone | 1-800-969-0639 |
| quality@osteocentric.com | |
| Phone | 1-800-969-0639 |
| quality@osteocentric.com | |
| Phone | 1-800-969-0639 |
| quality@osteocentric.com | |
| Phone | 1-800-969-0639 |
| quality@osteocentric.com | |
| Phone | 1-800-969-0639 |
| quality@osteocentric.com | |
| Phone | 1-800-969-0639 |
| quality@osteocentric.com | |
| Phone | 1-800-969-0639 |
| quality@osteocentric.com | |
| Phone | 1-800-969-0639 |
| quality@osteocentric.com | |
| Phone | 1-800-969-0639 |
| quality@osteocentric.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810097802247 [Primary] |
| NKB | Thoracolumbosacral Pedicle Screw System |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810097802247]
Moist Heat or Steam Sterilization
[00810097802247]
Moist Heat or Steam Sterilization
[00810097802247]
Moist Heat or Steam Sterilization
[00810097802247]
Moist Heat or Steam Sterilization
[00810097802247]
Moist Heat or Steam Sterilization
[00810097802247]
Moist Heat or Steam Sterilization
[00810097802247]
Moist Heat or Steam Sterilization
[00810097802247]
Moist Heat or Steam Sterilization
[00810097802247]
Moist Heat or Steam Sterilization
[00810097802247]
Moist Heat or Steam Sterilization
[00810097802247]
Moist Heat or Steam Sterilization
[00810097802247]
Moist Heat or Steam Sterilization
[00810097802247]
Moist Heat or Steam Sterilization
[00810097802247]
Moist Heat or Steam Sterilization
[00810097802247]
Moist Heat or Steam Sterilization
[00810097802247]
Moist Heat or Steam Sterilization
[00810097802247]
Moist Heat or Steam Sterilization
[00810097802247]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-04-21 |
| Device Publish Date | 2023-04-13 |
| 00810074300001 - 4.0 x 12mm Screw Super Fastener, ST | 2023-06-20 4.0 x 12mm Screw Super Fastener, ST |
| 00810074300018 - 4.0 x 14mm Screw Super Fastener, ST | 2023-06-20 4.0 x 14mm Screw Super Fastener, ST |
| 00810074300025 - 4.0 x 16mm Screw Super Fastener, ST | 2023-06-20 4.0 x 16mm Screw Super Fastener, ST |
| 00810074300032 - 4.0 x 18mm Screw Super Fastener, ST | 2023-06-20 4.0 x 18mm Screw Super Fastener, ST |
| 00810074300049 - 4.0 x 20mm Screw Super Fastener, ST | 2023-06-20 4.0 x 20mm Screw Super Fastener, ST |
| 00810074300056 - 4.0 x 22mm Screw Super Fastener, ST | 2023-06-20 4.0 x 22mm Screw Super Fastener, ST |
| 00810074300063 - 4.0 x 24mm Screw Super Fastener, ST | 2023-06-20 4.0 x 24mm Screw Super Fastener, ST |
| 00810074300070 - 4.0 x 26mm Screw Super Fastener, ST | 2023-06-20 4.0 x 26mm Screw Super Fastener, ST |