| Primary Device ID | B756SBLDCUP60 |
| NIH Device Record Key | 7c86055d-cdb7-457e-9b6c-a3faf3cefa6c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Shukla Shoulder Blade S9SHLDR-BLADE |
| Version Model Number | SBLDCUP-6 |
| Company DUNS | 159009294 |
| Company Name | Shukla Medical |
| 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 | true |
| 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 | false |
| OTC Over-The-Counter | false |
| Phone | +1-727-626-2771 |
| CS@ShuklaMedical.com | |
| Phone | +1-727-626-2771 |
| CS@ShuklaMedical.com | |
| Phone | +1-727-626-2771 |
| CS@ShuklaMedical.com | |
| Phone | +1-727-626-2771 |
| CS@ShuklaMedical.com | |
| Phone | +1-727-626-2771 |
| CS@ShuklaMedical.com | |
| Phone | +1-727-626-2771 |
| CS@ShuklaMedical.com | |
| Phone | +1-727-626-2771 |
| CS@ShuklaMedical.com | |
| Phone | +1-727-626-2771 |
| CS@ShuklaMedical.com | |
| Phone | +1-727-626-2771 |
| CS@ShuklaMedical.com | |
| Phone | +1-727-626-2771 |
| CS@ShuklaMedical.com | |
| Phone | +1-727-626-2771 |
| CS@ShuklaMedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B756SBLDCUP60 [Primary] |
| HWM | Osteotome |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B756SBLDCUP60]
Moist Heat or Steam Sterilization
[B756SBLDCUP60]
Moist Heat or Steam Sterilization
[B756SBLDCUP60]
Moist Heat or Steam Sterilization
[B756SBLDCUP60]
Moist Heat or Steam Sterilization
[B756SBLDCUP60]
Moist Heat or Steam Sterilization
[B756SBLDCUP60]
Moist Heat or Steam Sterilization
[B756SBLDCUP60]
Moist Heat or Steam Sterilization
[B756SBLDCUP60]
Moist Heat or Steam Sterilization
[B756SBLDCUP60]
Moist Heat or Steam Sterilization
[B756SBLDCUP60]
Moist Heat or Steam Sterilization
[B756SBLDCUP60]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-08-09 |
| Device Publish Date | 2022-08-01 |
| B756SHN0470 | Flexible Osteotome Handle, Low-profile |
| B756SCS0630 | Shoulder Blade System Lid |
| B756SCS0620 | Shoulder Blade System Case |
| B756SBLDFLAT120 | Flat Blade, 12mm x 9cm |
| B756SBLDFLAT110 | Flat Blade, 12mm x 3cm |
| B756SBLDFIN20 | Fin Blade, Curved |
| B756SBLDFIN10 | Fin Blade, Straight |
| B756SBLDCUP90 | Cupped Blade, 12mm x 9cm |
| B756SBLDCUP80 | Cupped Blade, 12mm x 3cm |
| B756SBLDCUP70 | Cupped Blade, 6mm x 9cm |
| B756SBLDCUP60 | Cupped Blade, 6mm x 3cm |
| B756SBLDCUP110 | Reverse Stem Blade |
| B756SBLDCUP100 | Cupped Blade, 16mm x 5cm |
| B756SAD0160 | Male-to-Male Shoulder Hub Adapter |