FDA.reportPublic FDA data

AESCULAP

Primary DI
04046963364779
Brand
AESCULAP
Company
Aesculap AG
Model
MB657R
Catalog number
MB657R
Device description
SMITH-PTRSN OSTEOTOMES STR 205MM 7MM
Published
2020-05-06
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
GFIOSTEOTOME, MANUAL
HWMOSTEOTOME

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFIOsteotome, ManualGeneral, Plastic Surgery1
HWMOsteotomeGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046963364779PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046963364779040469633647794046963364779

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic osteotomeA chisel-like, one-piece manual surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, often flat, but can be curved (concave) in design, and is typically bevelled on both sides with sloping curves. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). 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
315018218
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
04046964680878COREHIP EXTENDEDNK1126TNK1126T2020-08-10
04046964681028COREHIP EXTENDEDNK1131TNK1131T2020-08-10
04046964681127COREHIP PRIMARYNK1201KNK1201K2020-08-10
04046964681189COREHIP PRIMARYNK1207KNK1207K2020-08-10
04046964681301COREHIP PRIMARYNK1209KNK1209K2020-08-10
04046964681349COREHIP PRIMARYNK1221KNK1221K2020-08-10
04046964681363COREHIP PRIMARYNK1223KNK1223K2020-08-10
04046964681387COREHIP PRIMARYNK1225KNK1225K2020-08-10
04046964681400COREHIP PRIMARYNK1227KNK1227K2020-08-10
04046964681424COREHIP PRIMARYNK1229KNK1229K2020-08-10
04046964681462COREHIP PRIMARYNK1241KNK1241K2020-08-10
04046964681486COREHIP PRIMARYNK1243KNK1243K2020-08-10
04046964681509COREHIP PRIMARYNK1245KNK1245K2020-08-10
04046964681523COREHIP PRIMARYNK1247KNK1247K2020-08-10
04046964681547COREHIP PRIMARYNK1249KNK1249K2020-08-10
04046963929435NOVOCARTFR719RFR719R2020-08-24
04046963933357NOVOCARTFR651RFR651R2020-08-24
04038653289509NOVOCARTFR661RFR661R2020-08-10
04046963565992NOVOCARTFR660SUFR660SU2020-04-24
04046963939588NOVOCARTFR744RFR744R2020-04-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776395384MillenniumAvalign Technologies, Inc.GFI2026-07-13
B756SBLDFLAT17010Shukla Blade S9BLADEShukla MedicalHWM2026-07-09
B756SBLDFLAT17020Shukla Blade S9BLADEShukla MedicalHWM2026-07-09
00810143904666SURGIPROSSurgipros, LLCHWM2026-06-01
00810143904673SURGIPROSSurgipros, LLCHWM2026-06-01
00810143907261SURGIPROSSurgipros, LLCHWM2026-06-01
00810143907278SURGIPROSSurgipros, LLCHWM2026-06-01
00810143907308SURGIPROSSurgipros, LLCHWM2026-06-01
00810143907315SURGIPROSSurgipros, LLCHWM2026-06-01
00810212930008SURGIPROSSurgipros, LLCHWM2026-06-01
00810212930015SURGIPROSSurgipros, LLCHWM2026-06-01
00810212930022SURGIPROSSurgipros, LLCHWM2026-06-01
00810212930039SURGIPROSSurgipros, LLCHWM2026-06-01
00810212930046SURGIPROSSurgipros, LLCHWM2026-06-01
00810212930053SURGIPROSSurgipros, LLCHWM2026-06-01
00810212930060SURGIPROSSurgipros, LLCHWM2026-06-01
00810212930077SURGIPROSSurgipros, LLCHWM2026-06-01
00810212930084SURGIPROSSurgipros, LLCHWM2026-06-01
00810212930091SURGIPROSSurgipros, LLCHWM2026-06-01
00810212930107SURGIPROSSurgipros, LLCHWM2026-06-01
00810212930114SURGIPROSSurgipros, LLCHWM2026-06-01
09348811099624INKAThe Trustee for KAISER FAMILY TRUSTHWM2026-03-18
09348811110442INKAThe Trustee for KAISER FAMILY TRUSTHWM2026-03-18
09348811111289INKAThe Trustee for KAISER FAMILY TRUSTHWM2026-03-18
10381780407515Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWM2018-05-03
10381780408567Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780408574Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780408581Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780408680Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780408703Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03