FDA.reportPublic FDA data

Knife

Primary DI
B97450524709
Brand
Knife
Company
DR.FRIGZ INTERNATIONAL(PVT)LTD,
Model
Lebsche Sternal Knife
Catalog number
505247
Device description
Lebsche Sternal Knife 1.25” blade, 10”
Published
2022-11-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KDGChisel (Osteotome)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDGChisel (Osteotome)General, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B97450524709PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Scalpel handle, single-useA sterile device that is an interchangeable component of a scalpel and that functions as a handle designed to mount a compatible blade. This device with the blade become a single-bladed surgical instrument intended to be used by a physician for cutting or dissecting tissue. The device is typically made of metal (e.g., stainless steel or brass). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length10Inch

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
645680125
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B974122000FORCEPSPEAN FORCEPS122002022-11-22
B9742370FORCEPSSPONGE FORCEPS2372022-11-22
B974818900FORCEPSPEAN FORCEPS818902022-11-22
B974AF25720S0EAR FORCEPSMICRO ALLIGATOR FORCEPSAF25720S2022-11-22
B974ATF8PAS0FORCEPSALLIS TISSUE FORCEPSATF8PAS2022-11-22
B974CF818000FORCEPSCRILE FORCEPSCF818002022-11-22
B974CF818100FORCEPSCRILE FORCEPSCF818102022-11-22
B974CK80400FORCEPSKELLY FORCEPSCK80402022-11-22
B974EA5850FORCEPSPEAN FORCEPSEA5852022-11-22
B974EA6000FORCEPSSPONGE FORCEPS EA6002022-11-22
B974EA6100FORCEPSALLIS TISSUE FORCEPSEA6102022-11-22
B974EA610S02FORCEPSALLIS TISSUE FORCEPSEA610S2022-11-22
B974EA8560FORCEPSALLIS TISSUE FORCEPSEA8562022-11-22
B974FS95000FORCEPSSPONGE FORCEPSFS9502022-11-22
B974IF10560FORCEPSLOWA PUNCTURING FORCEPSIF10562022-11-22
B974IF2250FORCEPSUMBILICAL FORCEPSIF2252022-11-22
B974MHS1020HAEMOSTATIC FORCEPSMOSQUITO FORCEPSMHS1022022-11-22
B974MHS102FS0FORCEPSMOSQUITO FORCEPSMHS102FS2022-11-22
B974MHS102L0FORCEPSMOSQUITO FORCEPSMHS102L2022-11-22
B974MHS102S0FORCEPSMOSQUITO FORCEPSMHS102S2022-11-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD921381110Surgical DirectSurgical Direct, Inc.KDG2026-02-12
B382SD9144841130Surgical DirectSurgical Direct, Inc.KDG2025-11-05
B382SD9144841180Surgical DirectSurgical Direct, Inc.KDG2025-11-05
B382SD9144841190Surgical DirectSurgical Direct, Inc.KDG2025-11-05
B382SD921613120Surgical DirectSurgical Direct, Inc.KDG2025-11-05
B382SD9233201100Surgical DirectSurgical Direct, Inc.KDG2025-11-05
B382SD9233201110Surgical DirectSurgical Direct, Inc.KDG2025-11-05
00198506086465ELMED INCORPORATEDELMED INCORPORATEDKDG2025-11-05
B382SD62622020Surgical DirectSurgical Direct, Inc.KDG2025-10-14
B382SD62622040Surgical DirectSurgical Direct, Inc.KDG2025-10-14
B382SD62622060Surgical DirectSurgical Direct, Inc.KDG2025-10-14
B382SD62622070Surgical DirectSurgical Direct, Inc.KDG2025-10-14
B382SD62622080Surgical DirectSurgical Direct, Inc.KDG2025-10-14
B382SD62622090Surgical DirectSurgical Direct, Inc.KDG2025-10-14
B382SD62622100Surgical DirectSurgical Direct, Inc.KDG2025-10-14
B382SD62622120Surgical DirectSurgical Direct, Inc.KDG2025-10-14
00810158217577PRINCETONPrinceton Medical Group, Inc.KDG2025-10-08
00810158216938PRINCETONPrinceton Medical Group, Inc.KDG2025-09-10
10840199528834Comfort Plus ChiselKOROS U.S.A., INC.KDG2025-01-31
10888277381339MEDLINEMEDLINE INDUSTRIES, INC.KDG2025-01-29
10888277392304MEDLINEMEDLINE INDUSTRIES, INC.KDG2025-01-29
10840199511423ChiselKOROS U.S.A., INC.KDG2024-12-31
10840199511430ChiselKOROS U.S.A., INC.KDG2024-12-31
10840199527394OsteotomeKOROS U.S.A., INC.KDG2024-12-31
10840199527400OsteotomeKOROS U.S.A., INC.KDG2024-12-31
10840199527417OsteotomeKOROS U.S.A., INC.KDG2024-12-31
10840199527424OsteotomeKOROS U.S.A., INC.KDG2024-12-31
10840199527431OsteotomeKOROS U.S.A., INC.KDG2024-12-31
10840199527448OsteotomeKOROS U.S.A., INC.KDG2024-12-31
10840199527455OsteotomeKOROS U.S.A., INC.KDG2024-12-31