FDA.reportPublic FDA data

Quattro®

Primary DI
M543CM9500
Brand
Quattro®
Company
CAYENNE MEDICAL, INC.
Model
CM-9500
Catalog number
CM-9500
Published
2019-03-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GABNeedle, Suturing, Disposable
GARSuture, Nonabsorbable, Synthetic, Polyamide
GATSuture, Nonabsorbable, Synthetic, Polyethylene
GAWSuture, Nonabsorbable, Synthetic, Polypropylene

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GABNeedle, Suturing, DisposableGeneral, Plastic Surgery1
GARSuture, Nonabsorbable, Synthetic, PolyamideGeneral, Plastic Surgery2
GATSuture, Nonabsorbable, Synthetic, PolyethyleneGeneral, Plastic Surgery2
GAWSuture, Nonabsorbable, Synthetic, PolypropyleneGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M543CM9500PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Polyolefin suture, multifilamentA multiple-strand (multifilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g., polyethylene) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached needle intended to be disposed of after single use. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device intended to be used in a sterile condition.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
606719685
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M543CM8010Quattro®CM-8010CM-80102019-03-29
M543CM6127BioWick SureLockCM-61272016-01-10
M543CM6255BioWick XCM-62552018-01-31
M543CM6265BioWick XCM-62652018-01-25
00887868269769BioWick® SureLock®CM-61272020-09-21
00887868269790BioWick® XCM-62552020-09-21
00887868269813BioWick® XCM-62652020-09-21
M5431100259901Ventix™1100259901100259902018-12-04
M5431100259921Ventix™1100259921100259922018-12-04
M543CM1025iFix®CM-10252015-10-09
M543CM1030iFix®CM-10302015-10-09
M543CM1130iFix®CM-11302015-10-09
M543CM1230iFix®CM-12302015-10-09
M543CM1720iFix®CM-17202015-10-09
M543CM1725iFix®CM-17252015-10-09
M543CM1820iFix®CM-18202015-10-09
M543CM1825iFix®CM-18252015-10-09
M543CM1830iFix®CM-18302015-10-09
M543CM1920iFix®CM-19202015-10-09
M543CM1925iFix®CM-19252015-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07649990202211Geomax Reamer S-PI-A2.3Surgical Fusion Technologies GmbHGAT2025-10-01
07649990202372Geomax Reamer S-PI-A3.0Surgical Fusion Technologies GmbHGAT2025-10-01
07649990202389Handle SSurgical Fusion Technologies GmbHGAT2025-10-01
07649990202396Geomax Reamer SetSurgical Fusion Technologies GmbHGAT2025-10-01
10192253052329DevonCardinal Health 200, LLCGAB2025-05-29
10192253052138DevonCardinal Health 200, LLCGAB2025-03-27
10192253052145DevonCardinal Health 200, LLCGAB2025-03-27
10192253052152DevonCardinal Health 200, LLCGAB2025-03-27
10192253052169DevonCardinal Health 200, LLCGAB2025-03-27
10192253052176DevonCardinal Health 200, LLCGAB2025-03-27
10192253052183DevonCardinal Health 200, LLCGAB2025-03-27
10192253052190DevonCardinal Health 200, LLCGAB2025-03-27
10192253052206DevonCardinal Health 200, LLCGAB2025-03-27
10192253052213DevonCardinal Health 200, LLCGAB2025-03-27
10192253052220DevonCardinal Health 200, LLCGAB2025-03-27
10192253052237DevonCardinal Health 200, LLCGAB2025-03-27
10192253052244DevonCardinal Health 200, LLCGAB2025-03-27
10192253052251DevonCardinal Health 200, LLCGAB2025-03-27
10192253052268DevonCardinal Health 200, LLCGAB2025-03-27
10192253052275DevonCardinal Health 200, LLCGAB2025-03-27
10192253052282DevonCardinal Health 200, LLCGAB2025-03-27
10192253052299DevonCardinal Health 200, LLCGAB2025-03-27
10192253052312DevonCardinal Health 200, LLCGAB2025-03-27
10192253052336DevonCardinal Health 200, LLCGAB2025-03-27
10192253052343DevonCardinal Health 200, LLCGAB2025-03-27
07757093013747SUTUMEDUnilene S.A.C.GAR2024-09-19
07757093013891SUTUMEDUnilene S.A.C.GAR2024-09-19
09353903030003Griplasty SystemFIELD ORTHOPAEDICS PTY LTDGAB2024-09-19