FDA.reportPublic FDA data

Karl Schumacher

Primary DI
00842517103221
Brand
Karl Schumacher
Company
Karl Schumacher Dental, LLC
Model
85.251.00L
Device description
Lid for Mixing Bowl 85.251.00
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
EHKCUP, PROPHYLAXIS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHKCup, ProphylaxisDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842517103221PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842517103221008425171032218425171032210842517103221

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose bowl, reusableA portable bowl or basin designed to be used for a variety of medical purposes such as containing fluids, carrying or holding instruments prior to or during a procedure, and collecting body waste or other matter. The design and shape can vary including round, oblong, deep or quite shallow. 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
00850079280366CavexHexa DentalEHK2026-01-22
00850079280373CavexHexa DentalEHK2026-01-22
00850079280380CavexHexa DentalEHK2026-01-22
00883205032638OpalCupsULTRADENT PRODUCTS, INC.EHK2025-03-11
06975492100023PBCDONGGUAN YILONG MEDICAL SUPPLIES CO.. LTD.EHK2025-01-09
TQ26PA25523S0Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EHK2024-10-31
TQ26PA25525F0Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EHK2024-10-31
10302730003243Young DentalYOUNG DENTAL MANUFACTURING I, LLCEHK2024-09-27
10302730003250Young DentalYOUNG DENTAL MANUFACTURING I, LLCEHK2024-09-27
10302730003267Young DentalYOUNG DENTAL MANUFACTURING I, LLCEHK2024-09-27
10302730003274Young DentalYOUNG DENTAL MANUFACTURING I, LLCEHK2024-09-27
00302730003284Young DentalYOUNG DENTAL MANUFACTURING I, LLCEHK2024-09-27
00302730003291Young DentalYOUNG DENTAL MANUFACTURING I, LLCEHK2024-09-27
00842517111578Karl SchumacherKarl Schumacher Dental, LLCEHK2024-03-01
00842517103214Karl SchumacherKarl Schumacher Dental, LLCEHK2024-02-27
00348783001181ProFlarePREMIER DENTAL PRODUCTS COMPANYEHK2023-10-26
00348783004564ProFlarePREMIER DENTAL PRODUCTS COMPANYEHK2023-10-26
00813360023424AllProTEAM TECHNOLOGIES, INC.EHK2023-07-25
00813360023431AllProTEAM TECHNOLOGIES, INC.EHK2023-07-25
00813360023448AllProTEAM TECHNOLOGIES, INC.EHK2023-07-25
00813360023455AllProTEAM TECHNOLOGIES, INC.EHK2023-07-25
00813360023462AllProTEAM TECHNOLOGIES, INC.EHK2023-07-25
00813360023479AllProTEAM TECHNOLOGIES, INC.EHK2023-07-25
00813360023486AllProTEAM TECHNOLOGIES, INC.EHK2023-07-25
00813360023493AllProTEAM TECHNOLOGIES, INC.EHK2023-07-25
00813360023509AllProTEAM TECHNOLOGIES, INC.EHK2023-07-25
00813360023516AllProTEAM TECHNOLOGIES, INC.EHK2023-07-25
00813360023523AllProTEAM TECHNOLOGIES, INC.EHK2023-07-25
00813360023530AllProTEAM TECHNOLOGIES, INC.EHK2023-07-25
00813360023547AllProTEAM TECHNOLOGIES, INC.EHK2023-07-25