FDA.reportPublic FDA data

AESCULAP

Primary DI
04038653053964
Brand
AESCULAP
Company
Aesculap AG
Model
OP389R
Catalog number
OP389R
Device description
"Round Cutting Knife, 45 °, angled, 10"" (250 mm), diam. 3,50 mm, round cutting"
Published
2020-04-20
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
JZYKNIFE, LARYNGEAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JZYKnife, LaryngealEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653053964PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653053964040386530539644038653053964

GMDN Terms#

Term, Definition table
TermDefinition
Scalpel, reusableA hand-held manual surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The device is typically made of high-grade stainless steel alloy. 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
DM exempt
true
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
00190776228200AvalignAvalign Technologies, Inc.JZY2023-09-28
00190776228217AvalignAvalign Technologies, Inc.JZY2023-09-28
00190776328061MILLENNIUMAvalign Technologies, Inc.JZY2023-09-28
04055207039137NARichard Wolf GmbHJZY2022-08-09
04055207039144NARichard Wolf GmbHJZY2022-08-09
04055207039151NARichard Wolf GmbHJZY2022-08-09
04055207039168NARichard Wolf GmbHJZY2022-08-09
00190776050191AvalignAvalign Technologies, Inc.JZY2021-11-03
00190660093402Ambler SurgicalAMBLER SURGICAL CORP.JZY2021-01-07
00190660093419Ambler SurgicalAMBLER SURGICAL CORP.JZY2021-01-07
00190660093426Ambler SurgicalAMBLER SURGICAL CORP.JZY2021-01-07
00190660093433Ambler SurgicalAMBLER SURGICAL CORP.JZY2021-01-07
04046826136338MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJZY2020-09-24
04046826136369MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJZY2020-09-24
04046826136376MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJZY2020-09-24
04046826136345MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJZY2020-09-24
M6334281900JEDMEDJEDMED INSTRUMENT COMPANYJZY2020-09-01
M6334282120JEDMEDJEDMED INSTRUMENT COMPANYJZY2020-09-01
M63342821210JEDMEDJEDMED INSTRUMENT COMPANYJZY2020-09-01
M6334282140JEDMEDJEDMED INSTRUMENT COMPANYJZY2020-09-01
M6334282160JEDMEDJEDMED INSTRUMENT COMPANYJZY2020-09-01
M6334282180JEDMEDJEDMED INSTRUMENT COMPANYJZY2020-09-01
M6334282200JEDMEDJEDMED INSTRUMENT COMPANYJZY2020-09-01
04038653180622AESCULAPAesculap AGJZY2020-06-17
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10381780086246Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZY2018-10-24
10381780086260Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZY2018-10-24
10381780086291Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZY2018-10-24
10381780086307Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZY2018-10-24
10381780074946Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZY2018-09-17