| Primary Device ID | B922F00400480 |
| NIH Device Record Key | 337e35c7-8cb8-43cd-8aec-e02083de9c65 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Parallel Distractor |
| Version Model Number | F004.0048 |
| Catalog Number | F004.0048 |
| Company DUNS | 860396609 |
| Company Name | INDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED |
| 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 | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B922F00400480 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B922F00400480]
Moist Heat or Steam Sterilization
[B922F00400480]
Moist Heat or Steam Sterilization
[B922F00400480]
Moist Heat or Steam Sterilization
[B922F00400480]
Moist Heat or Steam Sterilization
[B922F00400480]
Moist Heat or Steam Sterilization
[B922F00400480]
Moist Heat or Steam Sterilization
[B922F00400480]
Moist Heat or Steam Sterilization
[B922F00400480]
Moist Heat or Steam Sterilization
[B922F00400480]
Moist Heat or Steam Sterilization
[B922F00400480]
Moist Heat or Steam Sterilization
[B922F00400480]
Moist Heat or Steam Sterilization
[B922F00400480]
Moist Heat or Steam Sterilization
[B922F00400480]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-08-18 |
| Device Publish Date | 2023-08-10 |
| B922F00400100 | Parallel Distractor |
| B922F00400480 | Parallel Distractor |