FDA.reportPublic FDA data

NOIR

Primary DI
04046964725807
Brand
NOIR
Company
Aesculap AG
Model
FT530B
Catalog number
FT530B
Device description
"YASARGIL NOIR Clip Applier Forceps, adjustable, 8 3/4"", (220 mm), working length: 3 1/2"", (90 mm), bayonet-shaped, narrow pattern, with ratchet, stainless steel, black, non-sterile, reusable"
Published
2022-05-06
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
K211572000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211572000Aesculap Slim Clip ApplierAesculap, Inc.2021-12-13HCI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046964725807PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046964725807040469647258074046964725807

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
04046963929435NOVOCARTFR719RFR719R2020-08-24
04046963933357NOVOCARTFR651RFR651R2020-08-24
04038653289509NOVOCARTFR661RFR661R2020-08-10
04046963565992NOVOCARTFR660SUFR660SU2020-04-24
04046963939588NOVOCARTFR744RFR744R2020-04-24
04038653201563NOVOCARTFR686RFR686R2020-04-23
04038653403912NOVOCARTFR721RFR721R2020-04-23
04038653403929NOVOCARTFR722RFR722R2020-04-23
04038653403936NOVOCARTFR723RFR723R2020-04-23
04038653403943NOVOCARTFR724RFR724R2020-04-23
04038653403950NOVOCART 3DFR725RFR725R2020-04-23
04038653403967NOVOCARTFR726RFR726R2020-04-23
04038653403974NOVOCARTFR727RFR727R2020-04-23
04038653422357NOVOCARTFR730RFR730R2020-04-23
04038653422388NOVOCARTFR731RFR731R2020-04-23
04046963315498NOVOCARTFR737RFR737R2020-04-23
04046963315504NOVOCARTFR738RFR738R2020-04-23
04046963315511NOVOCARTFR739RFR739R2020-04-23
04046963315528NOVOCARTFR740RFR740R2020-04-23
04038653201556NOVOCARTFR685RFR685R2020-04-22

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
04046964725814NOIRAesculap AGHCI2022-05-06