| Primary Device ID | B756SBLDACE001560 |
| NIH Device Record Key | cb6726da-315d-40b0-b8d3-8b701f533581 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Shukla Acetabular Cup - S9CUP |
| Version Model Number | SBLDACE001-56 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B756SBLDACE001560 [Primary] |
| HWB | Extractor |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B756SBLDACE001560]
Moist Heat or Steam Sterilization
[B756SBLDACE001560]
Moist Heat or Steam Sterilization
[B756SBLDACE001560]
Moist Heat or Steam Sterilization
[B756SBLDACE001560]
Moist Heat or Steam Sterilization
[B756SBLDACE001560]
Moist Heat or Steam Sterilization
[B756SBLDACE001560]
Moist Heat or Steam Sterilization
[B756SBLDACE001560]
Moist Heat or Steam Sterilization
[B756SBLDACE001560]
Moist Heat or Steam Sterilization
[B756SBLDACE001560]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2024-09-11 |
| Device Publish Date | 2023-09-12 |
| B756SMS054020 | OD Polly Radii Gauge 48-60mm |
| B756SMS054010 | OD Polly Radii Gauge 34-47mm |
| B756SMS049030 | OD Cup Measuring Gauge 50-60mm |
| B756SMS049020 | OD Cup Measuring Gauge 44-50mm |
| B756SMS049010 | OD Cup Measuring Gauge 34-43mm |
| B756SMS0480 | ID Radii Gauge Assembly |
| B756SBD204600 | Centering Bob 60mm |
| B756SBD204580 | Centering Bob 58mm |
| B756SBD204560 | Centering Bob 56mm |
| B756SBD204540 | Centering Bob 54mm |
| B756SBD204520 | Centering Bob 52mm |
| B756SBD204510 | Centering Bob 51mm |
| B756SBD204500 | Centering Bob 50mm |
| B756SBD204490 | Centering Bob 49mm |
| B756SBD204480 | Centering Bob 48mm |
| B756SBD204470 | Centering Bob 47mm |
| B756SBD204460 | Centering Bob 46mm |
| B756SBD204450 | Centering Bob 45mm |
| B756SBD204440 | Centering Bob 44mm |
| B756SBD204430 | Centering Bob 43mm |
| B756SBD204420 | Centering Bob 42mm |
| B756SBD204410 | Centering Bob 41mm |
| B756SBD204400 | Centering Bob 40mm |
| B756SBD204380 | Centering Bob 38mm |
| B756SBD204360 | Centering Bob 36mm |
| B756SBD204340 | Centering Bob 34mm |
| B756SBD066080 | Centering Ball 44mm |
| B756SBD066070 | Centering Ball 40mm |
| B756SBD066060 | Centering Ball 36mm |
| B756SBD066050 | Centering Ball 32mm |
| B756SBD066040 | Centering Ball 30mm |
| B756SBD066030 | Centering Ball 28mm |
| B756SBD066020 | Centering Ball 26mm |
| B756SBD066010 | Centering Ball 22mm |
| SBLDACE70SP1 | Blades, Ace Cup, 70mm, Starter & Finisher, Single Use, Sterile Packed |
| SBLDACE68SP1 | Blades, Ace Cup, 68mm, Starter & Finisher, Single Use, Sterile Packed |
| SBLDACE66SP1 | Blades, Ace Cup, 66mm, Starter & Finisher, Single Use, Sterile Packed |
| SBLDACE64SP1 | Blades, Ace Cup, 64mm, Starter & Finisher, Single Use, Sterile Packed |
| SBLDACE62SP1 | Blades, Ace Cup, 62mm, Starter & Finisher, Single Use, Sterile Packed |
| SBLDACE60SP1 | Blades, Ace Cup, 60mm, Starter & Finisher, Single Use, Sterile Packed |
| SBLDACE58SP1 | Blades, Ace Cup, 58mm, Starter & Finisher, Single Use, Sterile Packed |
| SBLDACE56SP1 | Blades, Ace Cup, 56mm, Starter & Finisher, Single Use, Sterile Packed |
| SBLDACE54SP1 | Blades, Ace Cup, 54mm, Starter & Finisher, Single Use, Sterile Packed |
| SBLDACE52SP1 | Blades, Ace Cup, 52mm, Starter & Finisher, Single Use, Sterile Packed |
| SBLDACE48SP1 | Blades, Ace Cup, 48mm, Starter & Finisher, Single Use, Sterile Packed |
| SBLDACE46SP1 | Blades, Ace Cup, 46mm, Starter & Finisher, Single Use, Sterile Packed |
| SBLDACE44SP1 | Blades, Ace Cup, 44mm, Starter & Finisher, Single Use, Sterile Packed |
| SBLDACE42SP1 | Blades, Ace Cup, 42mm, Starter & Finisher, Single Use, Sterile Packed |
| SBLDACE050SP1 | Blades, Ace Cup, 50mm, Starter & Finisher, Single Use, Sterile Packed |
| SBLDACE72SP1 | Blades, Ace Cup, 72mm, Starter & Finisher, Single Use, Sterile Packed |