FDA.reportPublic FDA data

Chord-X® Chordal Sizer

Primary DI
00877234001918
Brand
Chord-X® Chordal Sizer
Company
Artivion, Inc.
Model
CXCS
Catalog number
CXCS
Device description
Chord-X Chordal Sizer
Published
2026-10-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00877234001925PackageGS15In Commercial Distribution
00851788001495PreviousGS10
00877234001918PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00877234001925008772340019258772340019250877234001925
00851788001495008517880014958517880014950851788001495
00877234001918008772340019188772340019180877234001918

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00The storage environment should be clean, cool, and dry.

Contacts#

Phone, Email table
PhoneEmail
888-427-9654customerservice.us@artivion.com

Regulatory Flags#

DUNS number
119253177
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00877234001727Chord-X® Premeasured Loops, 24mm loop (3/8 circle)CXL-20-1838-24CXL-20-1838-242026-10-30
00877234001741Chord-X® Premeasured Loops, 20mm loop (3/8 circle)CXL-20-1838-20CXL-20-1838-202026-10-30
00877234001765Chord-X® Premeasured Loops, 16mm loop (3/8 circle)CXL-20-1838-16CXL-20-1838-162026-10-30
00877234001789Chord-X® Premeasured Loops, 12mm loop (3/8 circle)CXL-20-1838-12CXL-20-1838-122026-10-30
00877234001802Chord-X® Suture System, Adjustable (3/8 circle)CXL-20-1838-0CXL-20-1838-02026-10-30
00877234001826Chord-X® Premeasured Loops, 24mm loop (1/2 circle)CXL-20-1812-24CXL-20-1812-242026-10-30
00877234001840Chord-X® Premeasured Loops, 20mm loop (1/2 circle)CXL-20-1812-20CXL-20-1812-202026-10-30
00877234001864Chord-X® Premeasured Loops, 16mm loop (1/2 circle)CXL-20-1812-16CXL-20-1812-162026-10-30
00877234001888Chord-X® Premeasured Loops, 12mm loop (1/2 circle)CXL-20-1812-12CXL-20-1812-122026-10-30
00877234001901Chord-X® Suture System, Adjustable (1/2 circle)CXL-20-1812-0CXL-20-1812-02026-10-30
00877234001420AMDS Hybrid Prosthesis ("AMDS")K060004AMDS40c2026-08-07
00877234001437AMDS Hybrid Prosthesis ("AMDS")K060005AMDS4030c2026-08-07
00877234001444AMDS Hybrid Prosthesis ("AMDS")K060006AMDS552026-08-07
00877234001451AMDS Hybrid Prosthesis ("AMDS")K060007AMDS55402026-08-07
00877234001635PhotoFix Decellularized Bovine PericardiumPFP6X8PFP6X82026-05-29
00877234001642PhotoFix Decellularized Bovine PericardiumPFP0.8X8PFP0.8X82026-05-29
00877234001659PhotoFix Decellularized Bovine PericardiumPFP1X6PFP1X62026-05-29
00877234001666PhotoFix Decellularized Bovine PericardiumPFP4X4PFP4X42026-05-29
00877234001673PhotoFix Decellularized Bovine PericardiumPFP2X9PFP2X92026-05-29
00877234001680PhotoFix Decellularized Bovine PericardiumPFP1X10PFP1X102026-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776437404MillenniumAvalign Technologies, Inc.MDM2026-11-02
00190776437411MillenniumAvalign Technologies, Inc.MDM2026-11-02
B35671626000American MedicalsAmerican MedicalsMDM2026-11-02
B3567162600250American MedicalsAmerican MedicalsMDM2026-11-02
00190776437237MillenniumAvalign Technologies, Inc.MDM2026-10-30
00888867620940Arthrex®ARTHREX, INC.MDM2026-10-29
00190776436834MillenniumAvalign Technologies, Inc.MDM2026-10-22
07540277009663RMAC Surgical MarkerRMAC Surgical, IncMDM2026-10-21
00190776435080MillenniumAvalign Technologies, Inc.MDM2026-10-15
00840456225332JMUJMU DENTAL, INCMDM2026-10-13
00840456225349JMUJMU DENTAL, INCMDM2026-10-13
06955045515634hoboatJiangsu Hope Biomedical Science&Technology Co.,Ltd.MDM2026-10-13
06955045515689hoboatJiangsu Hope Biomedical Science&Technology Co.,Ltd.MDM2026-10-13
00190776434120MillenniumAvalign Technologies, Inc.MDM2026-10-09
00190776434229MillenniumAvalign Technologies, Inc.MDM2026-10-09
00190776433840MillenniumAvalign Technologies, Inc.MDM2026-10-08
00190776433857MillenniumAvalign Technologies, Inc.MDM2026-10-08
00190776433673MillenniumAvalign Technologies, Inc.MDM2026-10-07
00190776436162MillenniumAvalign Technologies, Inc.MDM2026-10-07
G141526051160Carnegie Surgical LLCCarnegie Surgical LLCMDM2026-10-07
00190776433536MillenniumAvalign Technologies, Inc.MDM2026-10-06
00190776434311MillenniumAvalign Technologies, Inc.MDM2026-10-06
00810220800584Adler Instrument CompanyAdler, Inc.MDM2026-09-30
00190776432775MillenniumAvalign Technologies, Inc.MDM2026-09-29
00888867618961Arthrex®ARTHREX, INC.MDM2026-09-28
00888867621237Arthrex®ARTHREX, INC.MDM2026-09-28
10888277689251MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689268MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689282MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689299MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28