FDA.reportPublic FDA data

Scalpel Handle

Primary DI
G2231103340
Brand
Scalpel Handle
Company
Medetz Surgical Instruments LLC
Model
11-0334
Device description
"# 9 knife handle, 5"", holds blades 10, 11, 12 & 15"
Published
2022-04-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
G2231103340PrimaryHIBCC0

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
8004205135emichaels@medetzsurgical.com

Regulatory Flags#

DUNS number
876570990
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
G22312643590Medetz Surgical Instruments12-643592026-04-09
G2231349550Ophthalmic Scissors13-49552026-04-09
G223140461200Medetz Surgical Instruments14-0461202026-04-09
G22351091I0Medetz Surgical Instruments5-1091-I2026-04-09
G2231135500Medetz Surgical Instruments11-35502025-12-16
G2231135900Medetz Surgical Instruments11-35902025-12-16
G2233K0Medetz Surgical Instruments3k2023-07-17
G2231124410Medetz Surgical Instruments11-24412023-04-11
G22313100Medetz Surgical Instruments13102022-02-23
G2231394680Sinskey lens manipulating hook13-94682025-12-16
G223M1129350Femtosecond Spatulam11-29352025-12-16
G223111991RC0Medetz Surgical Instruments11-1991rc2025-11-05
G2231139450Medetz Surgical Instruments11-39452025-11-05
G22312270490Medetz Surgical Instruments12-270492025-11-05
G22312647930Medetz Surgical Instruments12-647932025-11-05
G223140200700Medetz Surgical Instruments14-0200-7.02025-11-05
G223M1120880Colibri Forcepm11-20882025-11-05
G22312624110Medetz Surgical Instruments12-624112025-09-10
G223113858L0Medetz Surgical Instruments11-3858L2025-09-05
G2231140730Medetz Surgical Instruments11-40732025-09-05

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