FDA.reportPublic FDA data

AESCULAP

Primary DI
04038653431083
Brand
AESCULAP
Company
Aesculap AG
Model
FE918K
Catalog number
FE918K
Device description
"KOPITNIK AVM Clip Applier, working length: 3 1/2"", (90 mm), bayonet-shaped, with ratchet, non-sterile, reusable"
Published
2016-05-31
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
HCIAPPLIER, ANEURYSM CLIP

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCIApplier, Aneurysm ClipNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653431083PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653431083040386534310834038653431083

GMDN Terms#

Term, Definition table
TermDefinition
Aneurysm clip applierA surgical instrument designed for the application/insertion of aneurysm clips (devices for approximating the edges of the neck of an aneurysm or for the prevention of bleeding from small individual blood vessels). 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
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04038653042586AESCULAPET251RET251R2016-09-23
04046964227547AESCULAPGF058BGF058B2016-09-23
04038653148998AESCULAPDO706RDO706R2020-04-21
04038653105878AESCULAPLS059RLS059R2020-04-21
04038653106080AESCULAPLS099RLS099R2020-04-21
04038653034666AESCULAPDE419RDE419R2020-06-17
04038653034697AESCULAPDE422RDE422R2020-06-17
04038653105977AESCULAPLS084RLS084R2022-07-29
04038653199020AESCULAPXG105RXG105R2021-10-15
04038653199006AESCULAPXG103RXG103R2020-08-24
04038653199013AESCULAPXG104RXG104R2020-08-24
04038653460533AESCULAPXG106RXG106R2020-08-24
04046963000431AESCULAPXG107RXG107R2020-08-24
04046963000448AESCULAPXG108RXG108R2020-08-24
04046963611538AESCULAPXG126RXG126R2020-08-24
04038653109999AESCULAPND118RND118R2020-05-08
04038653110018AESCULAPND121RND121R2020-05-08
04038653110056AESCULAPND125RND125R2020-05-06
04038653201303PROCARTFR600RFR600R2020-04-22
04038653088690AESCULAPFK352RFK352R2020-04-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250603753025LAZICPeter Lazic GmbHHCI2025-10-01
04250603753049LAZICPeter Lazic GmbHHCI2025-08-26
04250603753032LAZICPeter Lazic GmbHHCI2025-08-05
04250603749264LAZICPeter Lazic GmbHHCI2024-10-30
04250603747390LAZICPeter Lazic GmbHHCI2024-08-02
04250603700197LAZICPeter Lazic GmbHHCI2024-02-06
04250603700241LAZICPeter Lazic GmbHHCI2024-02-06
04250603700487LAZICPeter Lazic GmbHHCI2024-02-06
04250603700524LAZICPeter Lazic GmbHHCI2024-02-06
04250603700579LAZICPeter Lazic GmbHHCI2024-02-06
04250603700876LAZICPeter Lazic GmbHHCI2024-02-06
04250603700883LAZICPeter Lazic GmbHHCI2024-02-06
04250603700890LAZICPeter Lazic GmbHHCI2024-02-06
04250603701057LAZICPeter Lazic GmbHHCI2024-02-06
04946329397734Sugita AVM Microclip II Single Shaft ApplierMIZUHO CORPORATIONHCI2023-12-28
04946329397741Sugita AVM Microclip II Single Shaft ApplierMIZUHO CORPORATIONHCI2023-12-28
04946329397758Sugita AVM Microclip II Single Shaft ApplierMIZUHO CORPORATIONHCI2023-12-28
04946329397765Sugita AVM Microclip II Single Shaft ApplierMIZUHO CORPORATIONHCI2023-12-28
04946329397772Sugita AVM Microclip II Single Shaft ApplierMIZUHO CORPORATIONHCI2023-12-28
04946329397789Sugita AVM Microclip II Single Shaft ApplierMIZUHO CORPORATIONHCI2023-12-28
04946329397710Sugita AVM Microclip II ApplierMIZUHO CORPORATIONHCI2023-12-19
04946329397727Sugita AVM Microclip II ApplierMIZUHO CORPORATIONHCI2023-12-19
04946329397888Sugita AVM Microclip ApplierMIZUHO CORPORATIONHCI2023-03-09
04046955823352AESCULAPAESCULAP, INC.HCI2023-01-24
04250603747239LAZICPeter Lazic GmbHHCI2022-12-13
04046964725470NOIRAesculap AGHCI2022-05-06
04046964725487NOIRAesculap AGHCI2022-05-06
04046964725494NOIRAesculap AGHCI2022-05-06
04046964725791NOIRAesculap AGHCI2022-05-06
04046964725807NOIRAesculap AGHCI2022-05-06