FDA.reportPublic FDA data

Karl Schumacher

Primary DI
00842517106642
Brand
Karl Schumacher
Company
Karl Schumacher Dental, LLC
Model
BWW0931
Device description
Grn Bone Spltng Wedge Set, 2x2.2mm Tpr
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
EMMCHISEL, OSTEOTOME, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMMChisel, Osteotome, SurgicalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842517106642PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842517106642008425171066428425171066420842517106642

GMDN Terms#

Term, Definition table
TermDefinition
Periosteal elevator, reusableA hand-held manual surgical instrument designed to lift/separate (elevate) or tunnel under the periosteum during surgery, typically orthopaedic, including use on the ribs. It may in addition be used in dentistry to access retained roots, or to remove them with surrounding bone. It is typically a one-piece instrument available in a variety of sizes and blade designs, including straight and curved blades, and often double-ended with a central handle; it is made of metal [e.g., stainless steel, titanium (Ti)]. 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
ESAM13290011STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13290021STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13290031STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13290041STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13291011STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13291021STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13291031STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13291041STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13310011STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13310021STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13310031STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13310041STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13310051STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13310061STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13311011STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13311021STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13311031STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13311041STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13311051STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13311061STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13333011STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13333021STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13333031STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13333041STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13333051STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13333061STOMA®Storz am Mark GmbHEMM2020-08-27
10649111069406Sklar®SKLAR CORPORATIONEMM2018-10-22
10649111069710Sklar®SKLAR CORPORATIONEMM2018-10-22
10649111069765Sklar®SKLAR CORPORATIONEMM2018-10-22
10649111070082Sklar®SKLAR CORPORATIONEMM2018-10-22