FDA.reportPublic FDA data

AESCULAP

Primary DI
04046955661602
Brand
AESCULAP
Company
AESCULAP, INC.
Model
TEK8219R
Catalog number
TEK8219R
Device description
MINI SLIM TI CLIP APPLIER 90MMX15DEGRHT
Published
2020-12-08
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

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
04046955661602PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046955661602040469556616024046955661602

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
DM exempt
false
Premarket exempt
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04046964993312AESCULAPMG223RMG223R2026-01-16
04046964993329AESCULAPMG224RMG224R2026-01-16
04046955741212AESCULAPFK900NBFK900NB2025-08-17
04046955741229AESCULAPFK901NBFK901NB2025-08-17
04046955741236AESCULAPFK902NBFK902NB2025-08-17
04046955741243AESCULAPFK903NBFK903NB2025-08-17
04046955741250AESCULAPFK904NBFK904NB2025-08-17
04046955741267AESCULAPFK906NBFK906NB2025-08-17
04046955741274AESCULAPFK907NBFK907NB2025-08-17
04046955741281AESCULAPFK908NBFK908NB2025-08-17
04046955741298AESCULAPFK909NBFK909NB2025-08-17
04046955741304AESCULAPFK910NBFK910NB2025-08-17
04046955741311AESCULAPFK960NBFK960NB2025-08-17
04046955741328AESCULAPFK913NBFK913NB2025-08-17
04046955741335AESCULAPFK914NBFK914NB2025-08-17
04046955741342AESCULAPFK915NBFK915NB2025-08-17
04046955741359AESCULAPFK916NBFK916NB2025-08-17
04046955741366AESCULAPFK917NBFK917NB2025-08-17
04046955741373AESCULAPFK961NBFK961NB2025-08-17
04046955741380AESCULAPFK962NBFK962NB2025-08-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
04046964725470NOIRAesculap AGHCI2022-05-06
04046964725487NOIRAesculap AGHCI2022-05-06
04046964725494NOIRAesculap AGHCI2022-05-06
04046964725791NOIRAesculap AGHCI2022-05-06
04046964725807NOIRAesculap AGHCI2022-05-06
04046964725814NOIRAesculap AGHCI2022-05-06
04046964725821NOIRAesculap AGHCI2022-05-06
04046964725838NOIRAesculap AGHCI2022-05-06