FDA.reportPublic FDA data

CONMED

Primary DI
10845854024256
Brand
CONMED
Company
Conmed Corporation
Model
18.00015
Catalog number
18.00015
Device description
SUTURE PASSER, SHARP, ARTHROSCOPIC
Published
2020-09-24
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
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
30845854024250Direct MarkingGS10
10845854024256PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3084585402425030845854024250
1084585402425610845854024256

GMDN Terms#

Term, Definition table
TermDefinition
Suturing unit, reusableA non-powered, hand-held device intended to pass sutures or a needle/suture assembly through tissues/prosthetic materials to facilitate suturing during an endoscopic and/or open surgical procedure; it may also knot, cut and/or tighten the sutures/ligature loop during or after placement. It typically consists of a shaft with hooks, catches, clasps, or forceps-like jaws at the distal end, and a proximal handle with controls. It typically has a pointed/cutting component to create a suture tunnel, and is loaded with the sutures or the suture is inserted through the shaft. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)237-0169CUSTOMER_SERVICE@CONMED.COM

Regulatory Flags#

DUNS number
071595540
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
30845854655478ConMed AirsealSHELF-ICARTSHELF-ICART2026-09-18
20845854082482ParadigmPEZS01APEZS01A2020-11-16
20845854015466SEQUENTMR007CMR007C2015-10-24
20845854036584SEQUENTMR004CMR004C2015-10-24
10653405044703CORE DYNAMICSCD1406CD14062026-03-23
10653405045083CORE DYNAMICSCD1608FHCD1608FH2026-03-24
20653405990908GENESYS™ CrossFT™CFBC-4502RCFBC-4502R2026-07-31
20653405990915GENESYS™ CrossFT™CFBC-4503RCFBC-4503R2026-07-31
20653405990922GENESYS™ CrossFT™CFBC-5502RCFBC-5502R2026-07-31
20653405990939GENESYS™ CrossFT™CFBC-5503RCFBC-5503R2026-07-31
20653405990946GENESYS™ CrossFT™CFBC-6502RCFBC-6502R2026-07-31
20653405990953GENESYS™ CrossFT™CFBC-6503RCFBC-6503R2026-07-31
10653405000242YANKAUER003447000344702016-09-24
10845854035559E9000E9015E90152026-03-24
20653405008559CONMED60-0824-00160-0824-0012016-09-24
30653405003230CONMED1380111380112016-09-24
30653405003247CONMED1380121380122016-09-24
30653405058230AER DEFENSE60-8084-00160-8084-0012016-09-24
30845854655492PlumeSafe® X5™PX5-1354-22PX5-1354-222026-07-23
20845854042004Y-KNOTYH01YH012015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888867574489Arthrex®ARTHREX, INC.MDM2026-09-18
00888867574496Arthrex®ARTHREX, INC.MDM2026-09-18
00888867574502Arthrex®ARTHREX, INC.MDM2026-09-18
00888867574519Arthrex®ARTHREX, INC.MDM2026-09-18
00888867574526Arthrex®ARTHREX, INC.MDM2026-09-18
00888867574533Arthrex®ARTHREX, INC.MDM2026-09-18
10888277688896MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-18
10888277688902MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-18
10888277688919MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-18
10888277688926MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-18
10888277688933MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-18
10888277688940MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-18
10888277688957MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-18
10888277688964MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-18
10888277689121MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-18
10080196321384MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277688995MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689008MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689015MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689022MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689039MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689046MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689053MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689060MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689077MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689084MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689091MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689107MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689114MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10080196320417MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-09