FDA.reportPublic FDA data

RESOURCE

Primary DI
04046955210152
Brand
RESOURCE
Company
AESCULAP, INC.
Model
MB127ZR
Catalog number
MB127ZR
Device description
MG NO 3LA KNIFE HANDLE 200MM
Published
2020-05-08
Public version status
New
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
04046955210152PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046955210152040469552101524046955210152

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)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags#

DUNS number
082594540
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
04046964823794AESCULAPMF320MF3202026-04-18
04046964759895VEGAMG985RMG985R2020-10-16
04046964759925VEGAMG982RMG982R2020-10-16
04046964759956VEGAMG981RMG981R2020-10-16
04046964993312AESCULAPMG223RMG223R2026-01-16
04046964993329AESCULAPMG224RMG224R2026-01-16
04046955077069AESCULAPUS137US1372020-08-10
04046955077076AESCULAPUS138US1382020-08-10
04046955066544AESCULAPMG512RMG512R2020-09-26
04046955076550AESCULAPMG065RMG065R2020-09-26
04046955076611AESCULAPMG182RMG182R2020-08-25
04046964759970VEGAMG980RMG980R2020-10-16
04046955919369AESCULAPUS981SUUS981SU2025-10-31
04046955919383AESCULAPUS982SUUS982SU2025-10-31
04046955919406AESCULAPUS983SUUS983SU2025-10-31
04046955920327AESCULAPUS984SUUS984SU2025-10-31
04046955920341AESCULAPUS985SUUS985SU2025-10-31
04046955920365AESCULAPUS986SUUS986SU2025-10-31
04046955920389AESCULAPUS987SUUS987SU2025-10-31
04046955920402AESCULAPUS988SUUS988SU2025-10-31

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