FDA.reportPublic FDA data

Karl Schumacher

Primary DI
00842517118713
Brand
Karl Schumacher
Company
Karl Schumacher Dental, LLC
Model
ENA6419
Device description
Enamel Hatchet #419, 1.0mm, L/R
Published
2024-05-06
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
EKDINSTRUMENT, CUTTING, OPERATIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKDInstrument, Cutting, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842517118713PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842517118713008425171187138425171187130842517118713

GMDN Terms#

Term, Definition table
TermDefinition
Bone cutting forceps, reusableA strongly constructed, hand-held, surgical instrument used for cutting posterior rib ends and bone tissue during a surgical procedure. It typically has very strong, sharp, angled cutting blades attached to strong, sprung (self-opening), pivoted or multi-pivoted handles that, when squeezed together, close the blades so that they cut entirely through the bone. It is available in various sizes and is made of high-grade stainless steel. 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
00348783008333Premier Cavity PrepPREMIER DENTAL PRODUCTS COMPANYEKD2026-04-02
00348783008340Premier Cavity PrepPREMIER DENTAL PRODUCTS COMPANYEKD2026-04-02
00348783008357Premier Cavity PrepPREMIER DENTAL PRODUCTS COMPANYEKD2026-04-02
00348783012248Premier Cavity PrepPREMIER DENTAL PRODUCTS COMPANYEKD2026-04-02
00348783008265Premier Cavity PrepPREMIER DENTAL PRODUCTS COMPANYEKD2026-04-01
00348783008272Premier Cavity PrepPREMIER DENTAL PRODUCTS COMPANYEKD2026-04-01
00348783008289Premier Cavity PrepPREMIER DENTAL PRODUCTS COMPANYEKD2026-04-01
00348783008319Premier Cavity PrepPREMIER DENTAL PRODUCTS COMPANYEKD2026-04-01
00840018635838NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635845NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635852NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635869NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635876NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635883NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635890NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635906NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635913NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635920NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635937NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635944NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635951NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635968NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635975NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635982NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635999NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018636002NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018636019NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018636026NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018636033NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018636040NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02