FDA.reportPublic FDA data

HU-FRIEDY

Primary DI
10889950040987
Brand
HU-FRIEDY
Company
HU-FRIEDY MFG. CO., LLC
Model
10-130-03E
Catalog number
10-130-03E
Device description
#3 Scalpel Handle
Published
2020-08-14
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
GDZHANDLE, SCALPEL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDZHandle, ScalpelGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889950040987PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088995004098710889950040987

GMDN Terms#

Term, Definition table
TermDefinition
Scalpel handle, reusableA 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 reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)483-7433info@hu-friedy.com

Regulatory Flags#

DUNS number
005085972
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
10889950157326Hu-FriedyIMNO24511C2026-05-26
10889950147020Hu-FriedyDSBH5/662026-04-17
10889950157180Hu-FriedyIM40580-C42026-04-07
10889950157197Hu-FriedyIMN9142HAS2026-04-07
10889950126339Hu-Friedy MFG Co., LLC.CLAWXS2026-04-06
10889950126346Hu-Friedy MFG Co., LLC.CLAWS2026-04-06
10889950126353Hu-Friedy MFG Co., LLC.CLAWM2026-04-06
10889950126360Hu-Friedy MFG Co., LLC.CLAWL2026-04-06
10889950126377Hu-Friedy MFG Co., LLC.CLAWXL2026-04-06
10889950126384Hu-Friedy MFG Co., LLC.CLAWXSX2026-04-06
10889950126391Hu-Friedy MFG Co., LLC.CLAWSX2026-04-06
10889950126407Hu-Friedy MFG Co., LLC.CLAWMX2026-04-06
10889950126414Hu-Friedy MFG Co., LLC.CLAWLX2026-04-06
10889950126421Hu-Friedy MFG Co., LLC.CLAWXLX2026-04-06
10889950001643Hu-Friedy Mfg. Co., LLCPSN6953LPSN6953L2015-10-16
10889950001834Hu-Friedy Mfg. Co., LLCPSN7773LPSN7773L2015-10-16
10889950002060Hu-Friedy Mfg. Co., LLCPSNR683LPSNR683L2015-10-16
10889950002077Hu-Friedy Mfg. Co., LLCPSNR698LPSNR698L2015-10-16
10889950002084Hu-Friedy Mfg. Co., LLCPSNR7772LPSNR7772L2015-10-16
10889950156008Hu-FriedyIM53FMC22026-03-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776421533MillenniumAvalign Technologies, Inc.GDZ2026-05-05
00190776419769MillenniumAvalign Technologies, Inc.GDZ2026-04-15
00190776419776MillenniumAvalign Technologies, Inc.GDZ2026-04-15
00190776419783MillenniumAvalign Technologies, Inc.GDZ2026-04-15
00190776418410MillenniumAvalign Technologies, Inc.GDZ2026-03-25
09348811000040INKAThe Trustee for KAISER FAMILY TRUSTGDZ2025-11-19
B382SD9045551000Surgical DirectSurgical Direct, Inc.GDZ2025-09-10
B382SD9045551010Surgical DirectSurgical Direct, Inc.GDZ2025-09-10
B382SD9045551020Surgical DirectSurgical Direct, Inc.GDZ2025-09-10
B382SD9045551030Surgical DirectSurgical Direct, Inc.GDZ2025-09-10
16945630137621index AsuritySterilance Medical (Suzhou) Inc.GDZ2025-08-25
16945630137638index AsuritySterilance Medical (Suzhou) Inc.GDZ2025-08-25
38886354702639Anzen Safety ScalpelMEDIPURPOSE PTE. LTD.GDZ2025-02-12
B382SD904320210Surgical DirectSurgical Direct, Inc.GDZ2024-07-11
M944AL019130Wexler Surgical, Inc.WEXLER SURGICAL, INC.GDZ2024-02-12
M944AL019230Wexler Surgical, Inc.WEXLER SURGICAL, INC.GDZ2024-02-12
14026704922991PILLINGTELEFLEX INCORPORATEDGDZ2023-11-07
10620974003318SPSS Safety Scalpel Metal HandleSouthmedic IncorporatedGDZ2023-02-07
10620974003325SPSS Safety Scalpel Metal HandleSouthmedic IncorporatedGDZ2023-02-07
10620974003332SPSS Safety Scalpel Metal HandleSouthmedic IncorporatedGDZ2023-02-07
10620974003349SPSS Safety Scalpel Metal HandleSouthmedic IncorporatedGDZ2023-02-07
10620974003356SPSS Safety Scalpel Metal HandleSouthmedic IncorporatedGDZ2023-02-07
G25001001030Scalpel Handle No.3N S SURGICAL COMPANYGDZ2023-01-31
G25001002040Scalpel Handle No.4N S SURGICAL COMPANYGDZ2023-01-31
07708626670395SAMPEDROINDUSTRIAS MEDICAS SAMPEDRO S A SGDZ2023-01-18
B356BH103010American MedicalsAmerican MedicalsGDZ2023-01-02
00386120012230MYCOMYCO MEDICAL SUPPLIES INC.GDZ2022-12-09
00386120012247MYCOMYCO MEDICAL SUPPLIES INC.GDZ2022-12-09
00386120012254MYCOMYCO MEDICAL SUPPLIES INC.GDZ2022-12-09
00386120012261MYCOMYCO MEDICAL SUPPLIES INC.GDZ2022-12-09