FDA.reportPublic FDA data

Karl Schumacher

Primary DI
00842517110403
Brand
Karl Schumacher
Company
Karl Schumacher Dental, LLC
Model
EXP1308
Device description
Explorer #1308Pig Tail (2A)
Published
2024-03-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EKBEXPLORER, OPERATIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKBExplorer, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842517110403PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842517110403008425171104038425171104030842517110403

GMDN Terms#

Term, Definition table
TermDefinition
Dental surgical probe, reusableA slender, rod-like, hand-held manual dental surgical instrument intended to be used to explore, measure and/or perform therapeutic procedures during various types of dental surgical intervention. The distal end may be needle-like, hooked, or blunt; it is made of flexible or rigid metallic and/or synthetic polymer material and it may have scaled markings for measurements. 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
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
00842517104129Karl SchumacherASP0000Y2025-04-23
00842517112568Karl SchumacherNEE06862025-04-23
00842517112582Karl SchumacherNEE06892025-04-23
00842517112599Karl SchumacherNEE06902025-04-23
00842517112629Karl SchumacherNEE06912025-04-23
00842517112780Karl SchumacherNEE07902025-04-23
00842517112803Karl SchumacherNEE07912025-04-23
00842517111417Karl SchumacherHEM06102025-02-05
00842517111424Karl SchumacherHEM06112025-02-05
00842517112209Karl SchumacherMOS06122025-02-05
00842517112216Karl SchumacherMOS06132025-02-05
00842517103603Karl SchumacherAMCBGMS2024-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00348783005929Premier ExplorersPREMIER DENTAL PRODUCTS COMPANYEKB2026-03-17
00348783005974Premier ExplorersPREMIER DENTAL PRODUCTS COMPANYEKB2026-03-17
00348783005998Premier ExplorersPREMIER DENTAL PRODUCTS COMPANYEKB2026-03-17
00348783006018Premier ExplorersPREMIER DENTAL PRODUCTS COMPANYEKB2026-03-17
00348783006056Premier ExplorersPREMIER DENTAL PRODUCTS COMPANYEKB2026-03-17
00348783006063Premier ExplorersPREMIER DENTAL PRODUCTS COMPANYEKB2026-03-17
00348783006186Premier ExplorersPREMIER DENTAL PRODUCTS COMPANYEKB2026-03-17
00348783006223Premier ExplorersPREMIER DENTAL PRODUCTS COMPANYEKB2026-03-17
G149TBSEXP111201TBS DentalACME ENTERPRISE.EKB2026-03-02
00840018673229Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKB2026-02-11
00840018674127Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKB2026-02-11
00840018667150Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKB2026-02-10
00840018666108Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKB2026-02-09
00840018663688Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKB2026-02-04
00840018664012Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKB2026-02-04
08800019151548Endodontic ExplorerB& L Biotech, inc.EKB2025-04-30
EZPF2474460HZU0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEKB2025-03-07
EZPF2474465HZU0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEKB2025-03-07
00889813065242Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKB2024-12-18
00889813065303Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKB2024-12-18
00889813065143Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKB2024-12-12
00889813065266Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKB2024-12-12
00889813065136Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKB2024-11-30
00889813065150Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKB2024-11-30
00889813065174Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKB2024-11-30
00889813065181Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKB2024-11-30
00889813065198Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKB2024-11-30
00889813065204Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKB2024-11-30
00889813065228Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKB2024-11-30
00889813065235Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKB2024-11-30