FDA.reportPublic FDA data

NA

Primary DI
30845854024250
Brand
NA
Company
Conmed Corporation
Model
18.00015
Catalog number
18.00015
Device description
SUTURE PASSER, SHARP, ARTHROSCOPIC
Published
2020-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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 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; it may in addition knot and/or cut the sutures as they are placed. 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
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
20845854042028Y-KNOTYH02YH022015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10080196320516MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-05
10080196320493MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-04
00190776423841MillenniumAvalign Technologies, Inc.MDM2026-08-26
00190776427641MillenniumAvalign Technologies, Inc.MDM2026-08-26
00810158217409PRINCETONPrinceton Medical Group, Inc.MDM2026-08-25
00850088713626PRINCETONPrinceton Medical Group, Inc.MDM2026-08-25
04054462913602evonosevonos GmbH & Co. KGMDM2026-08-25
04054462913619evonosevonos GmbH & Co. KGMDM2026-08-25
04054462913626evonosevonos GmbH & Co. KGMDM2026-08-25
04054462913909evonosevonos GmbH & Co. KGMDM2026-08-25
04054462913916evonosevonos GmbH & Co. KGMDM2026-08-25
04054462913923evonosevonos GmbH & Co. KGMDM2026-08-25
04054462913947evonosevonos GmbH & Co. KGMDM2026-08-25
04054462913978evonosevonos GmbH & Co. KGMDM2026-08-25
04054462913985evonosevonos GmbH & Co. KGMDM2026-08-25
04054462913992evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914364evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914388evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914395evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914418evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914425evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914814evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914845evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914852evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914906evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914975evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914982evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914999evonosevonos GmbH & Co. KGMDM2026-08-25
04054462915002evonosevonos GmbH & Co. KGMDM2026-08-25
04054462915019evonosevonos GmbH & Co. KGMDM2026-08-25