FDA.report

AESCULAP

Primary DI
04038653176366
Brand
AESCULAP
Company
Aesculap AG
Model
OF600R
Catalog number
OF600R
Device description
POLITZER Sickle Knife, 6 1/2" (165 mm)
Published
2020-04-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
JYPKNIFE, MYRINGOTOMY

Product Code Classifications

CodeDeviceSpecialtyClass
JYPKnife, MyringotomyEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04038653176366PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04038653176366040386531763664038653176366

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags

DUNS number
315018218
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04038653177035AESCULAPOG963ROG963R2016-09-23
04038653242962AESCULAPDF262RDF262R2020-06-17
04038653339563AESCULAPJG901JG9012025-03-22
04038653345038AESCULAPJG910JG9102020-05-20
04038653038244AESCULAPDP511RDP511R2020-06-17
04038653038251AESCULAPDP512RDP512R2020-06-17
04038653038282AESCULAPDP540RDP540R2020-06-17
04038653038299AESCULAPDP541RDP541R2020-06-17
04038653038305AESCULAPDP542RDP542R2020-06-17
04038653177011AESCULAPOG961ROG961R2016-09-23
04038653251407AESCULAPOG960ROG960R2016-09-23
04038653044207MIASPAS MINI-ALIFFF569RFF569R2020-06-17
04038653044214MIASPAS MINI-ALIFFF571RFF571R2020-06-17
04038653044252MIASPAS MINI-ALIFFF578RFF578R2020-06-17
04038653044283MIASPAS MINI-ALIFFF586RFF586R2020-06-17
04038653117307AESCULAPNH196NH1962017-01-27
04038653117352AESCULAPNH206NH2062017-01-27
04038653118540AESCULAPNK088NK0882015-11-11
04038653118557AESCULAPNK089NK0892015-09-24
04038653118564AESCULAPNK090NK0902015-09-24

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
09421901970499Adept Medical Myringotomy KnifeADEPT MEDICAL LIMITEDJYP2024-03-20
G586E7213700Novo SurgicalNOVO SURGICAL, INC.JYP2023-12-18
G586E7213780Novo SurgicalNOVO SURGICAL, INC.JYP2023-12-18
00840183515966BR Surgical, LLCBR Surgical, LLCJYP2023-04-03
00840183515973BR Surgical, LLCBR Surgical, LLCJYP2023-04-03
00842331167089Novo Surgical Inc. NOVO SURGICAL, INC.JYP2022-11-13
00842331148354Novo Surgical Inc. NOVO SURGICAL, INC.JYP2022-11-12
04046826103194MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJYP2020-09-24
04046826103200MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJYP2020-09-24
M633301705HH0JEDMEDJEDMED INSTRUMENT COMPANYJYP2020-09-01
M6333814000ADEPT MEDICALJEDMED INSTRUMENT COMPANYJYP2020-09-01
M633S3814020ADEPT MEDICALJEDMED INSTRUMENT COMPANYJYP2020-09-01
05060180254988EXMOOREXMOOR PLASTICS LIMITEDJYP2019-05-30
05060180255022EXMOOREXMOOR PLASTICS LIMITEDJYP2019-05-30
10381780082514Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYP2018-10-24
10381780084440Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYP2018-10-24
05060180250737EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11
05060180250744EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11
05060180250751EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11
05060180250768EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11
05060180250775EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11
05060180250782EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11
05060180256357EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11
05060180250928EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11
05060180250935EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11
05060180250942EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11
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05060180250966EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11
05060180250973EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11
05060180250980EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11