FDA.reportPublic FDA data

Karl Schumacher

Primary DI
00842517103276
Brand
Karl Schumacher
Company
Karl Schumacher Dental, LLC
Model
ADS0021
Device description
Abtmnt Drvr #21, Shrt, RA, Torx T6
Published
2024-02-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXCWRENCH

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXCWrenchOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842517103276PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842517103276008425171032768425171032760842517103276

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)523-2427custsvs@karlschumacher.com

Regulatory Flags#

DUNS number
101070070
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842517104747Karl SchumacherASP0016T2025-07-08
00842517112360Karl SchumacherNEE00022025-07-08
00842517112384Karl SchumacherNEE00062025-07-08
00842517112421Karl SchumacherNEE00082025-07-08
00842517112438Karl SchumacherNEE0008T2025-07-08
00842517112476Karl SchumacherNEE00112025-07-08
00842517112483Karl SchumacherNEE00122025-07-08
00842517116764Karl SchumacherSCI0667S2025-06-19
00842517108547Karl SchumacherELX0012L2024-03-18
00842517108554Karl SchumacherELX0012R2024-03-18
00842517108561Karl SchumacherELX0013L2024-03-18
00842517108578Karl SchumacherELX0013R2024-03-18
00842517108622Karl SchumacherELX03202024-03-18
00842517108639Karl SchumacherELX03212024-03-18
00842517108660Karl SchumacherELX03502024-03-18
00842517108677Karl SchumacherELX03512024-03-18
00842517104129Karl SchumacherASP0000Y2025-04-23
00842517112568Karl SchumacherNEE06862025-04-23
00842517112582Karl SchumacherNEE06892025-04-23
00842517112599Karl SchumacherNEE06902025-04-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10886982362964NASynthes GmbHHXC2026-05-04
08059386742273Orthopaedic Surgical InstrumentsCITIEFFE SRLHXC2025-11-05
1085007050056915mm CurvaFix Hex Wrench CURVAFIX, INC.HXC2025-10-22
10889981437794SpecialsSeaspine Orthopedics CorporationHXC2025-10-17
18059015376494ORTHOFIXORTHOFIX SRLHXC2025-03-31
18059015376029TRUELOK SYSTEMORTHOFIX SRLHXC2025-01-10
10840199540805Modified Kaufman Type Kidney ClampKOROS U.S.A., INC.HXC2024-01-31
08800068966230LOSPA Modular Knee SystemCorentec Co., LtdHXC2022-10-24
08800068964960LOSPA Modular Knee System Corentec Co., LtdHXC2022-10-23
10845854023976ULTRAPOWERConmed CorporationHXC2022-06-02
B07301K0360280Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380000Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380010Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380020Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380030Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380200Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380220Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380240Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380260Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380300Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380420Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380600Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380820Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380830Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380840Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380850Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0381200Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0381220Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
10886982195722NASynthes GmbHHXC2019-02-21
08809265159063Surgical InstrumentJeil Medical CorporationHXC2018-11-28