| Primary Device ID | B756SBLDCUP10 |
| NIH Device Record Key | 62997187-c013-4fbb-9dd6-7e1ccd7db7f7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Shukla Blade S9BLADE |
| Version Model Number | SBLDCUP-1 |
| 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 | +1-727-626-2770 |
| CS@ShuklaMedical.com | |
| Phone | +1-727-626-2770 |
| CS@ShuklaMedical.com | |
| Phone | +1-727-626-2770 |
| CS@ShuklaMedical.com | |
| Phone | +1-727-626-2770 |
| CS@ShuklaMedical.com | |
| Phone | +1-727-626-2770 |
| CS@ShuklaMedical.com | |
| Phone | +1-727-626-2770 |
| CS@ShuklaMedical.com | |
| Phone | +1-727-626-2770 |
| CS@ShuklaMedical.com | |
| Phone | +1-727-626-2770 |
| CS@ShuklaMedical.com | |
| Phone | +1-727-626-2770 |
| CS@ShuklaMedical.com | |
| Phone | +1-727-626-2770 |
| CS@ShuklaMedical.com | |
| Phone | +1-727-626-2770 |
| CS@ShuklaMedical.com | |
| Phone | +1-727-626-2770 |
| CS@ShuklaMedical.com | |
| Phone | +1-727-626-2770 |
| CS@ShuklaMedical.com | |
| Phone | +1-727-626-2770 |
| CS@ShuklaMedical.com | |
| Phone | +1-727-626-2770 |
| CS@ShuklaMedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B756SBLDCUP10 [Primary] |
| HWM | Osteotome |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B756SBLDCUP10]
Moist Heat or Steam Sterilization
[B756SBLDCUP10]
Moist Heat or Steam Sterilization
[B756SBLDCUP10]
Moist Heat or Steam Sterilization
[B756SBLDCUP10]
Moist Heat or Steam Sterilization
[B756SBLDCUP10]
Moist Heat or Steam Sterilization
[B756SBLDCUP10]
Moist Heat or Steam Sterilization
[B756SBLDCUP10]
Moist Heat or Steam Sterilization
[B756SBLDCUP10]
Moist Heat or Steam Sterilization
[B756SBLDCUP10]
Moist Heat or Steam Sterilization
[B756SBLDCUP10]
Moist Heat or Steam Sterilization
[B756SBLDCUP10]
Moist Heat or Steam Sterilization
[B756SBLDCUP10]
Moist Heat or Steam Sterilization
[B756SBLDCUP10]
Moist Heat or Steam Sterilization
[B756SBLDCUP10]
Moist Heat or Steam Sterilization
[B756SBLDCUP10]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-07-23 |
| Device Publish Date | 2021-07-15 |
| B756SBLDFLAT10 | BLADE, FLAT, 8MM X 5CM, SINGLE USE |
| B756SBLDFLAT20 | Blade, Flat, 8 mm x 11 cm, Single Use |
| B756SBLDFLAT90 | Blade, Flat, 6 mm x 3 cm, Single Use |
| B756SBLDFLAT80 | Blade, Flat, 20 mm x 11 cm, Single Use |
| B756SBLDFLAT70 | Blade, Flat, Round Tip, 20 mm x 11 cm, Single Use |
| B756SBLDFLAT60 | Blade, Flat, Round Tip, 12 mm x 5 cm, Single Use |
| B756SBLDFLAT50 | Blade, Flat, 12 mm x 5 cm, Single Use |
| B756SBLDFLAT40 | Blade, Flat, 10 mm x 11 cm, Single Use |
| B756SBLDFLAT30 | Blade, Flat, 10 mm x 5 cm, Single Use |
| B756SBLDFLAT100 | B;ade, Flat, 6mm x 9cm, Single Use |
| B756SMS0230 | Strike Plate, Assy, Extended |
| B756SMS0190 | Strike Plate |
| B756SIN0050 | Hammer Assy, Slide |
| B756SHN0120 | Handle Assy, Osteotome, Push-to-Connect |
| B756SCS0100 | Tray, Blade System |
| B756SCS0090 | Case, Blade System |
| B756SBLDZ40 | Blade, ESSE, Round tip, 8mm x 2mm, Single Use : For S9BLADE Spc. Order |
| B756SBLDZ30 | Blade, ESSE, Flat tip, 8mm x 2mm, Single Use:For S9BLADE Spc. Order |
| B756SBLDZ20 | Blade, Z, Round Tip, 16 mm x 2 cm, Single Use |
| B756SBLDZ10 | Blade, Z, Flat Tip, 16 mm x 2 cm, Single Use |
| B756SBLDCURVE40 | Blade, Curved, for medial Hip, 12 mm x 16 cm, Single Use |
| B756SBLDCURVE30 | Blade, Curved, for Medial Hip, 12 mm x 11 cm, Single Use |
| B756SBLDCURVE20 | Blade, Curved, for Lateral Hip, 12 mm x 16 cm, Single Use |
| B756SBLDCURVE10 | Blade, Curved, for Lateral Hip, 12 mm x 11 cm, Single Use |
| B756SBLDCUP50 | Blade, Cupped, 20 mm x 11 cm, Single Use |
| B756SBLDCUP40 | Blade, Cupped, 16 mm x 11 cm, Single Use |
| B756SBLDCUP30 | Blade, Cupped, 14 mm x 11 cm, Single Use |
| B756SBLDCUP20 | Blade, Cupped, 12 mm x 11 cm, Single Use |
| B756SBLDCUP10 | Blade, Cupped, 10 mm x 11 cm, Single Use |
| B756SBLDCALC10 | Blade, for Calcar, 8 mm x 3 cm, Single Use |
| B756SBLDFLAT1SP1 | BLADE, FLAT, 8MM X 5CM, SINGLE USE, STERILE PACKED |
| B756SBLDFLAT3SP0 | BLADE, FLAT, 10MM X 5CM, SINGLE USE, STERILE PACKED |
| B756SBLDFLAT140 | Blade, Flat, 12mm x 15cm, Single Use |
| B756SBLDFLAT130 | Blade, Flat, 10mm x 15cm, Single Use |