FDA.reportPublic FDA data

AESCULAP

Primary DI
04046955778522
Brand
AESCULAP
Company
AESCULAP, INC.
Model
TEK8112R
Catalog number
TEK8112R
Device description
MINI SLIM TI CLIP APPLIER 100MMX30DEG DN
Published
2022-04-11
Public version status
New
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180914000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180914000Aesculap Slim Clip ApplierAesculap, Inc.2018-04-17HCI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046955778522PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046955778522040469557785224046955778522

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
082594540
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04046955074525AESCULAPBH189RBH189R2020-05-08
04046955075249AESCULAPMB180RMB180R2020-05-08
04046955075409AESCULAPMB272RMB272R2020-05-08
04046955075836AESCULAPMB609RMB609R2020-05-08
04046955075935AESCULAPMB749RMB749R2020-05-08
04046955075942AESCULAPMB753RMB753R2020-05-08
04046955075959AESCULAPMB754RMB754R2020-05-08
04046955076017AESCULAPMB770RMB770R2020-05-08
04046955076024AESCULAPMB771RMB771R2020-05-08
04046955076130AESCULAPMB807RMB807R2020-05-08
04046955076147AESCULAPMB808RMB808R2020-05-08
04046955076277AESCULAPMB899RMB899R2020-05-08
04046955075256AESCULAPMB181RMB181R2020-05-07
04046955075966AESCULAPMB757RMB757R2020-05-07
04046955076109AESCULAPMB797RMB797R2020-05-07
04046955076253AESCULAPMB897RMB897R2020-05-07
04046955076260AESCULAPMB898RMB898R2020-05-07
04038653411818AESCULAPMB273RMB273R2020-04-23
04046955074532AESCULAPBH233RBH233R2020-04-23
04046955076543AESCULAPMG061RMG061R2020-09-26

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