FDA.reportPublic FDA data

AESCULAP

Primary DI
04038653147649
Brand
AESCULAP
Company
Aesculap AG
Model
DB838R
Catalog number
DB838R
Device description
PAR CHISEL KRAMER NEVINS MCKN1/2
Published
2020-05-20
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
EMMCHISEL, OSTEOTOME, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMMChisel, Osteotome, SurgicalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653147649PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653147649040386531476494038653147649

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic chiselA hand-held, single-blade surgical instrument, bevelled on one side, designed to cut and shape bone during orthopaedic surgery. 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, flat or curved [(concave) - also known as a hollow blade] in design. 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
08809918209862Convex OsteotomeOssvis Co., Ltd.EMM2023-12-16
08809918209879Convex OsteotomeOssvis Co., Ltd.EMM2023-12-16
ESAM13290011STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13290021STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13290031STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13290041STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13291011STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13291021STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13291031STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13291041STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13310011STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13310021STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13310031STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13310041STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13310051STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13310061STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13311011STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13311021STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13311031STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13311041STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13311051STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13311061STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13333011STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13333021STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13333031STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13333041STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13333051STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13333061STOMA®Storz am Mark GmbHEMM2020-08-27
10649111069406Sklar®SKLAR CORPORATIONEMM2018-10-22
10649111069710Sklar®SKLAR CORPORATIONEMM2018-10-22