FDA.reportPublic FDA data

Shukla Acetabular Cup - S9CUP

Primary DI
SBLDACE44SP1
Brand
Shukla Acetabular Cup - S9CUP
Company
Shukla Medical
Model
SBLDACE-44-SP
Device description
Blades, Ace Cup, 44mm, Starter & Finisher, Single Use, Sterile Packed
Published
2024-08-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWBExtractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWBExtractorOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
SBLDACE44SP1PackageHIBCC1In Commercial Distribution
SBLDACE44SP0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, single-useA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1-727-626-2770CS@ShuklaMedical.com

Regulatory Flags#

DUNS number
159009294
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B756SBLDFLAT17010Shukla Blade S9BLADESBLDFLAT-17-012026-07-09
B756SBLDFLAT17020Shukla Blade S9BLADESBLDFLAT-17-022026-07-09
B756007053001000Torque Wrench00705300100007053001002026-06-01
B756007053002000Torque Wrench Adaptor HEX 3.5mm00705300200007053002002026-06-01
B756STP071010Shukla Universal Modular Vise Grip SystemSTP071-012026-05-18
B756STP071020Shukla Universal Modular Vise Grip SystemSTP071-022026-05-18
B756STP072010Shukla Universal Modular Vise Grip SystemSTP072-012026-05-18
B756STP072020Shukla Universal Modular Vise Grip SystemSTP072-022026-05-18
B756STP073010Shukla Universal Modular Vise Grip SystemSTP073-022026-05-18
B756STP073020Shukla Universal Modular Vise Grip SystemSTP073-022026-05-18
B756STP0740Shukla Universal Modular Vise Grip SystemSTP0742026-05-18
B756STP0750Shukla Universal Modular Vise Grip SystemSTP0752026-05-18
B756STP0760Shukla Universal Modular Vise Grip SystemSTP0762026-05-18
B756STP0770Shukla Universal Modular Vise Grip SystemSTP0772026-05-18
B756STP0780Shukla Universal Modular Vise Grip SystemSTP0782026-05-18
B756STP0820Shukla Universal Modular Vise Grip SystemSTP0822026-05-18
B756STP0830Shukla Universal Modular Vise Grip SystemSTP0832026-05-18
B756STP0840Shukla Universal Modular Vise Grip SystemSTP0842026-05-18
B756STP0850Shukla Universal Modular Vise Grip SystemSTP0852026-05-18
B756STP0860Shukla Universal Modular Vise Grip SystemSTP0862026-05-18

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Primary DI, Brand, Company table
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00810017915958Slap HammerELEVATION SPINE, INC.HWB2026-08-14
00810017915965Slap Hammer AdaptorELEVATION SPINE, INC.HWB2026-08-14
03701089527965AMPLITUDEAMPLITUDE SASHWB2026-07-29
03701089527972AMPLITUDEAMPLITUDE SASHWB2026-07-29
03701089531276AMPLITUDEAMPLITUDE SASHWB2026-07-29
00889024711495Z1 ExtractorZimmer, Inc.HWB2026-07-20
08800068946966BENCOXCorentec Co., LtdHWB2026-07-01
08800068946973BENCOXCorentec Co., LtdHWB2026-07-01
08800068963666BENCOXCorentec Co., LtdHWB2026-07-01
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10603295543695ATTUNEDEPUY (IRELAND)HWB2025-10-31
00810135963411ImpactNVision Biomedical Technologies, Inc.HWB2025-09-24
00840314269737gSourceGSOURCE LLCHWB2025-05-05
00885556820964General InstrumentsSmith & Nephew, Inc.HWB2023-10-27
00818069011031TecometTECOMET INC.HWB2023-08-10
00818069011048TecometTECOMET INC.HWB2023-08-10
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00818069011062TecometTECOMET INC.HWB2023-08-10
00818069011079TecometTECOMET INC.HWB2023-08-10
00818069011086TecometTECOMET INC.HWB2023-08-10
00818069011093TecometTECOMET INC.HWB2023-08-10
00818069011109TecometTECOMET INC.HWB2023-08-10
00818069011116TecometTECOMET INC.HWB2023-08-10
00841435120365TecometTECOMET INC.HWB2022-10-03