| Primary Device ID | B922F00403270 |
| NIH Device Record Key | c7004a6c-be8e-45b9-8d44-747230094579 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ACURA Stabilization System - Rigid Screw Driver,SNAP ON (NT) |
| Version Model Number | F004.0327 |
| Catalog Number | F004.0327 |
| Company DUNS | 860396609 |
| Company Name | INDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED |
| 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 | 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 |
| Phone | +1214-972-8683 |
| info@indiusmedical.com | |
| Phone | +1214-972-8683 |
| info@indiusmedical.com | |
| Phone | +1214-972-8683 |
| info@indiusmedical.com | |
| Phone | +1214-972-8683 |
| info@indiusmedical.com | |
| Phone | +1214-972-8683 |
| info@indiusmedical.com | |
| Phone | +1214-972-8683 |
| info@indiusmedical.com | |
| Phone | +1214-972-8683 |
| info@indiusmedical.com | |
| Phone | +1214-972-8683 |
| info@indiusmedical.com | |
| Phone | +1214-972-8683 |
| info@indiusmedical.com | |
| Phone | +1214-972-8683 |
| info@indiusmedical.com | |
| Phone | +1214-972-8683 |
| info@indiusmedical.com | |
| Phone | +1214-972-8683 |
| info@indiusmedical.com | |
| Phone | +1214-972-8683 |
| info@indiusmedical.com | |
| Phone | +1214-972-8683 |
| info@indiusmedical.com | |
| Phone | +1214-972-8683 |
| info@indiusmedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B922F00403270 [Primary] |
| HXX | Screwdriver |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B922F00403270]
Moist Heat or Steam Sterilization
[B922F00403270]
Moist Heat or Steam Sterilization
[B922F00403270]
Moist Heat or Steam Sterilization
[B922F00403270]
Moist Heat or Steam Sterilization
[B922F00403270]
Moist Heat or Steam Sterilization
[B922F00403270]
Moist Heat or Steam Sterilization
[B922F00403270]
Moist Heat or Steam Sterilization
[B922F00403270]
Moist Heat or Steam Sterilization
[B922F00403270]
Moist Heat or Steam Sterilization
[B922F00403270]
Moist Heat or Steam Sterilization
[B922F00403270]
Moist Heat or Steam Sterilization
[B922F00403270]
Moist Heat or Steam Sterilization
[B922F00403270]
Moist Heat or Steam Sterilization
[B922F00403270]
Moist Heat or Steam Sterilization
[B922F00403270]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-04-05 |
| Device Publish Date | 2024-03-28 |
| B922A00470200 - ACURA Stabilization System | 2026-02-12 ACURA Stabilization System Ø 4.0 x 20 mm Polyaxial Screw - NT |
| B922A00470250 - ACURA Stabilization System | 2026-02-12 ACURA Stabilization System Ø 4.0 x 25 mm Polyaxial Screw - NT |
| B922A00470300 - ACURA Stabilization System | 2026-02-12 ACURA Stabilization System Ø 4.0 x 30 mm Polyaxial Screw - NT |
| B922A00470350 - ACURA Stabilization System | 2026-02-12 ACURA Stabilization System Ø 4.0 x 35 mm Polyaxial Screw - NT |
| B922A00470400 - ACURA Stabilization System | 2026-02-12 ACURA Stabilization System Ø 4.0 x 40 mm Polyaxial Screw - NT |
| B922A00470450 - ACURA Stabilization System | 2026-02-12 ACURA Stabilization System Ø 4.0 x 45 mm Polyaxial Screw - NT |
| B922A00471250 - ACURA Stabilization System | 2026-02-12 ACURA Stabilization System Ø 4.5 x 25 mm Polyaxial Screw - NT |
| B922A0047130 - ACURA Stabilization System | 2026-02-12 ACURA Stabilization System Ø 4.5 x 30 mm Polyaxial Screw - NT |