FDA.reportPublic FDA data

Aortic Repair Caliper

Primary DI
B040ARC100
Brand
Aortic Repair Caliper
Company
GENESEE BIOMEDICAL, INC.
Model
ARC-10
Device description
Aortic Repair Tool Kit - Cusp Calipers
Published
2024-12-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DWSInstruments, Surgical, Cardiovascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B040ARC10PackageHIBCC1In Commercial Distribution
B040ARC100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Aortic valve cusp height rulerA hand-held manual surgical instrument intended to be used during aortic valve repair and root remodelling to measure aortic valve cusp height. It is a double-ended graduated tool with one straight-edged end used to measure effective cusp height, and one hooked end used to measure geometric cusp height. It is typically available in a set of varying sizes. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
939872651
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B040RPS181100Thoracic Port with Obturator 18x110mmRPS-181102026-03-25
B040RPS18500Thoracic Port with Obturator 18x50mmRPS-18502026-03-25
B040RPS18700Thoracic Port with Obturator 18x70mmRPS-18702026-03-25
B040RPS18900Thoracic Port with Obturator 18x90mmRPS-18902026-03-25
B040TF260TransForm McCarthy Annuloplasty RingTF-262024-12-23
B040TF280TransForm McCarthy Annuloplasty RingTF-282024-12-23
B040TF300TransForm McCarthy Annuloplasty RingTF-302024-12-23
B040TF320TransForm McCarthy Annuloplasty RingTF-322024-12-23
B040TF340TransForm McCarthy Annuloplasty RingTF-342024-12-23
B040TF380TransForm McCarthy Annuloplasty RingTF-382024-12-23
B040TF400TransForm McCarthy Annuloplasty RingTF-402024-12-23
B040TF240TransForm McCarthy Annuloplasty RingTF-242024-12-23
B040TF26TransForm McCarthy Annuloplasty RingTF-262024-12-23
B040TF28TransForm McCarthy Annuloplasty RingTF-282024-12-23
B040TF30TransForm McCarthy Annuloplasty RingTF-302024-12-23
B040TF32TransForm McCarthy Annuloplasty RingTF-322024-12-23
B040TF34TransForm McCarthy Annuloplasty RingTF-342024-12-23
B040TF360TransForm McCarthy Annuloplasty RingTF-362024-12-23
B040TF38TransForm McCarthy Annuloplasty RingTF-382024-12-23
B040TF40TransForm McCarthy Annuloplasty RingTF-402024-12-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776429119MillenniumAvalign Technologies, Inc.DWS2026-09-04
00884450456217Merit Medical®Merit Medical Systems, Inc.DWS2026-09-04
00884450456224Merit Medical®Merit Medical Systems, Inc.DWS2026-09-04
00884450456231Merit Medical®Merit Medical Systems, Inc.DWS2026-09-04
04058749008944NAFehling Instruments GmbH & Co. KGDWS2026-09-04
04058749012521NAFehling Instruments GmbH & Co. KGDWS2026-09-04
04058749036350NAFehling Instruments GmbH & Co. KGDWS2026-09-04
04058749122626NAFehling Instruments GmbH & Co. KGDWS2026-09-04
00190776423933MillenniumAvalign Technologies, Inc.DWS2026-08-27
00190776423971MillenniumAvalign Technologies, Inc.DWS2026-08-27
00190776424114MillenniumAvalign Technologies, Inc.DWS2026-08-27
00190776424138MillenniumAvalign Technologies, Inc.DWS2026-08-27
00884450450970Merit Medical®Merit Medical Systems, Inc.DWS2026-08-27
00190776419707MillenniumAvalign Technologies, Inc.DWS2026-08-25
00190776420284MillenniumAvalign Technologies, Inc.DWS2026-08-25
00190776420390MillenniumAvalign Technologies, Inc.DWS2026-08-25
04058749004496NAFehling Instruments GmbH & Co. KGDWS2026-08-25
00190776417130MillenniumAvalign Technologies, Inc.DWS2026-08-19
00190776416973MillenniumAvalign Technologies, Inc.DWS2026-08-18
00190776417000MillenniumAvalign Technologies, Inc.DWS2026-08-18
00198506094064ELMED INCORPORATEDELMED INCORPORATEDDWS2026-08-18
00190776411107MillenniumAvalign Technologies, Inc.DWS2026-08-07
00190776411473MillenniumAvalign Technologies, Inc.DWS2026-08-07
00190776411497MillenniumAvalign Technologies, Inc.DWS2026-08-07
00190776411510MillenniumAvalign Technologies, Inc.DWS2026-08-07
00190776408732MillenniumAvalign Technologies, Inc.DWS2026-08-03
03661219141778DELACROIX-CHEVALIERLANDANGERDWS2026-08-02
03661219141785DELACROIX-CHEVALIERLANDANGERDWS2026-08-02
14026704916679PILLINGTELEFLEX INCORPORATEDDWS2026-08-01
00190776407438MillenniumAvalign Technologies, Inc.DWS2026-07-31