FDA.reportPublic FDA data

ELIMINATOR

Primary DI
20653405052477
Brand
ELIMINATOR
Company
Conmed Corporation
Model
000380
Catalog number
000380
Device description
CONMED ELIMINATOR 3-Stage Esophageal PET Balloon Dilator, 20 mm x 8 cm, 60F
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K033936000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033936000BARD ELIMINATOR PET BALLOON DILATORSC.R. Bard, Inc.2004-01-14KNQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20653405052477PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2065340505247720653405052477

GMDN Terms#

Term, Definition table
TermDefinition
Gastrointestinal/biliary dilation balloon catheterA long, thin, flexible tube with an inflatable balloon at its distal tip intended to be used for gastrointestinal and/or biliary intraluminal dilation; it is typically used to endoscopically dilate strictures of the oesophagus, pylorus, colon and/or biliary tract. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device may consist of one or more lumen, and may be of the fixed-wire or wire-guided type. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge60French
Device Size Text, specify0
Length8Millimeter
Outer Diameter20Centimeter
Pressure50Pound per Square Inch
Pressure3400millibar

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
071595540
Device count
1
Lot or batch
true
Expiration date on label
true

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
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
06959664927465NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664927496NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664928943NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664928974NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664929001NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664929032NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664929070NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664929100NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15