| Primary Device ID | 00843575108739 |
| NIH Device Record Key | 118f18bf-a7a5-4172-a6c2-6ec738a32989 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Slotted Pin Puller |
| Version Model Number | 8829003010 |
| Catalog Number | 8829003010 |
| Company DUNS | 081315444 |
| Company Name | B-ONE ORTHO, CORP. |
| 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 | true |
| 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 | 00843575108739 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00843575108739]
Moist Heat or Steam Sterilization
[00843575108739]
Moist Heat or Steam Sterilization
[00843575108739]
Moist Heat or Steam Sterilization
[00843575108739]
Moist Heat or Steam Sterilization
[00843575108739]
Moist Heat or Steam Sterilization
[00843575108739]
Moist Heat or Steam Sterilization
[00843575108739]
Moist Heat or Steam Sterilization
[00843575108739]
Moist Heat or Steam Sterilization
[00843575108739]
Moist Heat or Steam Sterilization
[00843575108739]
Moist Heat or Steam Sterilization
[00843575108739]
Moist Heat or Steam Sterilization
[00843575108739]
Moist Heat or Steam Sterilization
[00843575108739]
Moist Heat or Steam Sterilization
[00843575108739]
Moist Heat or Steam Sterilization
[00843575108739]
Moist Heat or Steam Sterilization
[00843575108739]
Moist Heat or Steam Sterilization
[00843575108739]
Moist Heat or Steam Sterilization
[00843575108739]
Moist Heat or Steam Sterilization
[00843575108739]
Moist Heat or Steam Sterilization
[00843575108739]
Moist Heat or Steam Sterilization
[00843575108739]
Moist Heat or Steam Sterilization
[00843575108739]
Moist Heat or Steam Sterilization
[00843575108739]
Moist Heat or Steam Sterilization
[00843575108739]
Moist Heat or Steam Sterilization
[00843575108739]
Moist Heat or Steam Sterilization
[00843575108739]
Moist Heat or Steam Sterilization
[00843575108739]
Moist Heat or Steam Sterilization
[00843575108739]
Moist Heat or Steam Sterilization
[00843575108739]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-03-15 |
| Device Publish Date | 2024-03-07 |
| 00843575116055 - Primo™ Acetabular System | 2026-02-19 Cementless Acetabular Shell, Full Hole; Porous Plasma Spray + HA Coating; 68mm Outer Diameter, Size L Liner |
| 00843575116062 - Primo™ Acetabular System | 2026-02-19 Cementless Acetabular Shell, Full Hole; Porous Plasma Spray + HA Coating; 70mm Outer Diameter, Size L Liner |
| 00843575116079 - Primo™ Acetabular System | 2026-02-19 Cementless Acetabular Shell, Full Hole; Porous Plasma Spray + HA Coating; 72mm Outer Diameter, Size L Liner |
| 00843575120168 - Primo™ Acetabular System | 2026-02-19 Shell Trial, 66MM OUTER DIAMETER x LINER SIZE L |
| 00843575120175 - Primo™ Acetabular System | 2026-02-19 Shell Trial, 68MM OUTER DIAMETER x LINER SIZE L |
| 00843575120182 - Primo™ Acetabular System | 2026-02-19 Shell Trial, 70MM OUTER DIAMETER x LINER SIZE L |
| 00843575120199 - Primo™ Acetabular System | 2026-02-19 Shell Trial, 72MM OUTER DIAMETER x LINER SIZE L |
| 00843575120205 - Primo™ Acetabular System | 2026-02-19 ACETABULAR REAMER, 66MM |