FDA.reportPublic FDA data

Lock-Stitch™ Procedure Kit

Primary DI
00887868270376
Brand
Lock-Stitch™ Procedure Kit
Company
CAYENNE MEDICAL, INC.
Model
CM9500
Catalog number
CM-9500
Published
2020-09-21
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
GARSuture, Nonabsorbable, Synthetic, Polyamide
OVNSuture Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GARSuture, Nonabsorbable, Synthetic, PolyamideGeneral, Plastic Surgery2
OVNSuture KitGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M543CM9500PreviousHIBCC0
00887868270376PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868270376008878682703768878682703760887868270376

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

Contacts#

Phone, Email table
PhoneEmail
+1(888)229-3661zimmer.consumerrelations@zimmerbiomet.com

Regulatory Flags#

DUNS number
606719685
Device count
1
Premarket exempt
true
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
00860011435938TAS Medical, Inc. Tissue Approximation SystemTAS Medical, Inc.GAR2026-08-01
00860011435945TAS Medical, Inc. Tissue Approximation SystemTAS Medical, Inc.GAR2026-08-01
00860011435952TAS Medical, Inc. Tissue Approximation SystemTAS Medical, Inc.GAR2026-08-01
00860011435969TAS Medical, Inc. Tissue Approximation SystemTAS Medical, Inc.GAR2026-08-01
14026704724106DEKNATELTELEFLEX INCORPORATEDOVN2026-08-01
14026704725066DEKNATELTELEFLEX INCORPORATEDOVN2026-08-01
14026704725073DEKNATELTELEFLEX INCORPORATEDOVN2026-08-01
14026704724120DEKNATELTELEFLEX INCORPORATEDOVN2026-07-29
14026704724182DEKNATELTELEFLEX INCORPORATEDOVN2026-07-29
10809160528006MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.OVN2026-07-28
10705031088054ETHILONETHICON, LLCGAR2026-07-03
10705031089600ETHILONETHICON, LLCGAR2026-07-03
10705031097018ETHILONETHICON, LLCGAR2026-07-03
10705031099975ETHILONETHICON, LLCGAR2026-07-03
10809160523155MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.OVN2026-06-09
10809160497081Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OVN2025-10-10
10197106742525CARDINAL HEALTHCardinal Health 200, LLCOVN2025-07-09
10809160476505Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OVN2025-07-09
10197106767030CARDINAL HEALTHCardinal Health 200, LLCOVN2025-06-02
10197106784396CARDINAL HEALTHCardinal Health 200, LLCOVN2024-10-01
07757093013747SUTUMEDUnilene S.A.C.GAR2024-09-19
07757093013891SUTUMEDUnilene S.A.C.GAR2024-09-19
10197106763810CARDINAL HEALTHCardinal Health 200, LLCOVN2024-09-06
10197106728055CARDINAL HEALTHCardinal Health 200, LLCOVN2024-08-01
10197106650721CARDINAL HEALTHCardinal Health 200, LLCOVN2024-07-10
10197106687505CARDINAL HEALTHCardinal Health 200, LLCOVN2024-07-02
10197106688946CARDINAL HEALTHCardinal Health 200, LLCOVN2024-06-07
10197106671962CARDINAL HEALTHCardinal Health 200, LLCOVN2024-05-21
10197106628997CARDINAL HEALTHCardinal Health 200, LLCOVN2024-04-30
10197106530979CARDINAL HEALTHCardinal Health 200, LLCOVN2024-04-05