FDA.reportPublic FDA data

ELIMINATOR

Primary DI
10653405052494
Brand
ELIMINATOR
Company
Conmed Corporation
Model
000735
Catalog number
000735
Device description
CONMED ELIMINATOR 3-Stage Esophageal PET Balloon Dilator, 15mm/45F, Multipack
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNQDilator, esophageal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNQDilator, EsophagealGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K940965000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K940965000ELIMINATOR BALLOON DILATORC.R. Bard, Inc.1994-05-20FGE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10653405052494PackageGS15In Commercial Distribution
20653405052491PrimaryGS10
00653405052497Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1065340505249410653405052494
2065340505249120653405052491
00653405052497006534050524976534050524970653405052497

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical handpiece/electrode holder, single-useA device intended to be used to house or fix an active electrosurgical handpiece/pen with its electrode when not being used by the surgeon during the surgical procedure. This is to secure the conducting unit, especially the electrode, within the sterile operating zone and protect it against potential adverse events. The holder will typically be fastened to an object within the sterile field (e.g., a drape, anaesthesia dividing arm, operating table). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge45French
Device Size Text, specify0
Device Size Text, specify0
Length8Centimeter
Outer Diameter15Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)237-0169CUSTOMER_SERVICE@CONMED.COM
+1(866)426-6633CustomerExperience@conmed.com

Regulatory Flags#

DUNS number
071595540
Device count
5
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20845854042004Y-KNOTYH01YH012015-10-24
20845854042028Y-KNOTYH02YH022015-10-24
10845854087534Infinity™QTSLQTSL2026-06-10
10845854087541Infinity™QTSRQTSR2026-06-10
10845854087558Infinity™RDBHRDBH2026-06-10
20653405990328Infinity™QTCRQTCR2026-06-10
20653405990366Infinity™ADB-0808ADB-08082026-06-10
20653405990373Infinity™ADB-0609ADB-06092026-06-10
20653405990380Infinity™ADB-0809ADB-08092026-06-10
20653405990397Infinity™ADB-0610ADB-06102026-06-10
20653405990403Infinity™ADB-0810ADB-08102026-06-10
20653405990410Infinity™ADB-0611ADB-06112026-06-10
20653405990427Infinity™DB-0808DB-08082026-06-10
20653405990434Infinity™DB-0609DB-06092026-06-10
20653405990441Infinity™DB-0809DB-08092026-06-10
20653405990458Infinity™DB-0610DB-06102026-06-10
20653405990465Infinity™DB-0810DB-08102026-06-10
20653405990472Infinity™DB-0611DB-06112026-06-10
10653405002765ABC® Bend-A-Beam®1340091340092016-09-24
10845854015506CONMEDC2630C26302015-12-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06936937786646STERIS CleanGuide™Jiangsu Grit Medical Technology Co., Ltd.KNQ2026-07-17
06936937792364STERIS CleanGuide™Jiangsu Grit Medical Technology Co., Ltd.KNQ2026-07-17
06936937792371STERIS CleanGuide™Jiangsu Grit Medical Technology Co., Ltd.KNQ2026-07-17
06936937792388STERIS CleanGuide™Jiangsu Grit Medical Technology Co., Ltd.KNQ2026-07-17
06936937792395STERIS CleanGuide™Jiangsu Grit Medical Technology Co., Ltd.KNQ2026-07-17
06936937792401STERIS CleanGuide™Jiangsu Grit Medical Technology Co., Ltd.KNQ2026-07-17
06936937792418STERIS CleanGuide™Jiangsu Grit Medical Technology Co., Ltd.KNQ2026-07-17
06936937792425STERIS CleanGuide™Jiangsu Grit Medical Technology Co., Ltd.KNQ2026-07-17
06959664925645NAHangzhou AGS MedTech Co., Ltd.KNQ2026-06-18
06959664925676NAHangzhou AGS MedTech Co., Ltd.KNQ2026-06-18
06959664925584NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664925614NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664925959NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664925980NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664926017NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664926048NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664926314NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664926345NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664926376NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664926406NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664926673NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664926703NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664926734NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664926765NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664927038NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664927069NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664927090NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664927120NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664927403NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664927434NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15