FDA.reportPublic FDA data

CoLink LapiFix

Primary DI
00810021866529
Brand
CoLink LapiFix
Company
In2Bones USA, LLC
Model
C01 N4011
Catalog number
C01 N4011
Device description
CoLink LapiFix ASSEMBLY RIGHT
Published
2024-12-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZXGuide, surgical, instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810021866529PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810021866529008100218665298100218665290810021866529

GMDN Terms#

Term, Definition table
TermDefinition
Staple line-reinforcement stripA sterile bioabsorbable device made of material derived from animal tissue intended to buttress staple lines and control leaks of blood, fluids, and air from around staple lines typically during cardiothoracic and abdominal surgeries. It is typically available as strips of material provided with an adhesive hydrogel to facilitate rehydration of the strips and their temporary adherence to the stapler loader unit before application of the staples with the strips to the tissue. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(866)426-6633CustomerExperience@conmed.com

Regulatory Flags#

DUNS number
079700711
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810021869773HerculesA04 S0047A04 S00472024-12-09
38101755018838IBS-BG01 N0251G01 N02512026-09-21
38101755018845IBS-BG01 N0252G01 N02522026-09-21
008100218611735MSP06 N0241P06 N02412019-06-14
008179060297345MSP06 N0261P06 N02612019-06-14
008179060297415MSP06 N0271P06 N02712019-06-14
008179060297585MSP06 N0281P06 N02812019-06-14
008179060297655MSP06 N0291P06 N02912019-06-14
00817906027921CoLinkP04 N0012P04 N00122018-10-22
00817906027945CoLinkP04 N0101P04 N01012018-10-22
00817906027952CoLinkP04 N0102P04 N01022018-10-22
00817906027969CoLinkP04 N0103P04 N01032018-10-22
00817906027976CoLinkP04 N0104P04 N01042018-10-22
00817906027983CoLinkP04 N0105P04 N01052018-10-22
00817906027990CoLinkP04 N0131P04 N01312018-10-22
00817906028003CoLinkP04 N0132P04 N01322018-10-22
00817906028010CoLinkP04 N0141P04 N01412018-10-22
00817906028027CoLinkP04 N0142P04 N01422018-10-22
00817906028034CoLinkP04 N0151P04 N01512018-10-22
00817906028041CoLinkP04 N0152P04 N01522018-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M739985202530Marking PinCAPTIVA SPINE, INC.FZX2026-10-23
M739985203530Marking PinCAPTIVA SPINE, INC.FZX2026-10-23
04250337117933Punching Adapter for Working TubeJoimax GmbHFZX2026-10-22
04250337119180Guiding Tube, eccentrically cannulated, redJoimax GmbHFZX2026-10-22
04250337119197Guiding Tube, eccentrically cannulated, purpleJoimax GmbHFZX2026-10-22
04250337119203Working Tube with Handle, oblique 45°Joimax GmbHFZX2026-10-22
04250337119562Guiding Tube, conicalJoimax GmbHFZX2026-10-22
04250337119579Guiding rod , conicalJoimax GmbHFZX2026-10-22
04250337119586Guiding rod , conicalJoimax GmbHFZX2026-10-22
04250337119593Working Tube with crown half teeth tipJoimax GmbHFZX2026-10-22
04250337119647Working Tube with handle, Standard lipJoimax GmbHFZX2026-10-22
04250337119678Guiding rod, conical, longitudinal slantedJoimax GmbHFZX2026-10-22
04250337119791Working Tube with long lipJoimax GmbHFZX2026-10-22
04250337120834Working tube, long lipJoimax GmbHFZX2026-10-22
04250337121862Working Tube with Handle, Standard LipJoimax GmbHFZX2026-10-22
04250337121909Working Tube with Handle, Standard LipJoimax GmbHFZX2026-10-22
04250337121916Working Tube with Handle, oblique 35°Joimax GmbHFZX2026-10-22
04250337121923Working Tube with Handle, oblique 35°Joimax GmbHFZX2026-10-22
04250337121930Working Tube with Handle, long lipJoimax GmbHFZX2026-10-22
04250337122029Guiding Rod, conicalJoimax GmbHFZX2026-10-22
04250337122036Guiding Rod, conical, greenJoimax GmbHFZX2026-10-22
00810055071210OviTex®TELA BIO, INC.FZX2026-10-21
00190446960362DYNANAIL HELIXMedshape, Inc.FZX2026-10-09
00190446960379DYNANAIL HELIXMedshape, Inc.FZX2026-10-09
10840143919350AtriClip® Selection GuideATRICURE, INC.FZX2026-10-09
06932503563857Additional Working ChannelMicro-Tech (Nanjing) Co., Ltd.FZX2026-09-30
06932503563864Additional Working ChannelMicro-Tech (Nanjing) Co., Ltd.FZX2026-09-30
06932503563871Additional Working ChannelMicro-Tech (Nanjing) Co., Ltd.FZX2026-09-30
00810112597462TriLEAPSynthes GmbHFZX2026-02-10
00810112597479TriLEAPSynthes GmbHFZX2026-02-10