FDA.reportPublic FDA data

CONMED

Primary DI
30653405053884
Brand
CONMED
Company
Conmed Corporation
Model
001429
Catalog number
001429
Device description
CONMED BITE BLOCK
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KTIBRONCHOSCOPE ACCESSORY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTIBronchoscope AccessoryEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30653405053884PackageGS1100In Commercial Distribution
20653405053887PrimaryGS10
00653405053883Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3065340505388430653405053884
2065340505388720653405053887
00653405053883006534050538836534050538830653405053883

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic bite block, basic, single-useA device intended to be inserted into a patient''s mouth to maintain oral patency during an endoscopic procedure primarily to protect the endoscope, introduced via the mouth, from the patient''s natural tendency to bite down on the instrument, thereby causing damage. The device is also intended to protect the tongue and teeth of the patient during endoscopy. It is a basic device and does not include additional functions/features such as lumen to support introduction of an oxygen (O2) line. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length27Millimeter
Width20Millimeter

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
100
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
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
10845854051399AirSealiAS8-dViAS8-dV2021-08-22
10845854084137AirSeal®iAS8-dVLiAS8-dVL2023-01-06
20653405037573CONMEDPCD10PCD102016-09-24
10653405063797CONMED75200752002026-03-24
00845854035590CONCEPTESA-5190ESA-51902026-03-24
10845854041116POWERPROPRO2000PRO20002026-03-24
10845854041291CONMEDLS7501LS75012026-03-24
00653405014952POOLE903507090350702026-03-24
20653405017759CONMEDD8324D83242026-03-24
20653405017766CONMEDD8324IID8324II2026-03-24
20653405019777CONMEDDA36-03DA36-032026-03-24
20653405022821CONMEDFSR1303FSR13032026-03-24
20653405022838CONMEDFSR1311FSR13112026-03-24
20653405022951CONMEDFSR1370FSR13702026-03-24
20653405023057CONMEDFSR1534FSR15342026-03-24
20653405023071CONMEDFSR1539FSR15392026-03-24
20653405023163CONMEDFSR1590FSR15902026-03-24
20653405023170CONMEDFSR1590-20FSR1590-202026-03-24
20653405023385CONMEDFSR380FSR3802026-03-24
20653405023545CONMEDFSR565FSR5652026-03-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860009430211Compass Steerable NeedleSERPEX MEDICAL INC.KTI2025-12-08
00860009430235Adapter SRA-1-01 SERPEX MEDICAL INC.KTI2025-12-08
10860009430249Adapter SRA-2-01 SERPEX MEDICAL INC.KTI2025-12-08
10816734023515BullDog®DIVERSATEK HEALTHCARE, INC.KTI2025-12-05
14953170458375Single Use Aspiration Needle NA-201SX-4021OLYMPUS MEDICAL SYSTEMS CORP.KTI2025-08-14
14953170458382Single Use Aspiration NeedleOLYMPUS MEDICAL SYSTEMS CORP.KTI2025-08-14
14953170458399Single Use Aspiration NeedleOLYMPUS MEDICAL SYSTEMS CORP.KTI2025-08-14
14953170458405Single Use Aspiration NeedleOLYMPUS MEDICAL SYSTEMS CORP.KTI2025-08-14
44026704721151PILLINGTELEFLEX INCORPORATEDKTI2025-07-11
14953170458412DISPOSABLE GRASPING FORCEPSOLYMPUS MEDICAL SYSTEMS CORP.KTI2025-05-14
06934184007088MultiStage®Dongguan TT Medical, Inc.KTI2025-02-10
06934184007095MultiStage®Dongguan TT Medical, Inc.KTI2025-02-10
06934184007101MultiStage®Dongguan TT Medical, Inc.KTI2025-02-10
06934184007118MultiStage®Dongguan TT Medical, Inc.KTI2025-02-10
06934184007125MultiStage®Dongguan TT Medical, Inc.KTI2025-02-10
06934184007132MultiStage®Dongguan TT Medical, Inc.KTI2025-02-10
06934184007149MultiStage®Dongguan TT Medical, Inc.KTI2025-02-10
06934184007156MultiStage®Dongguan TT Medical, Inc.KTI2025-02-10
06934184007163MultiStage®Dongguan TT Medical, Inc.KTI2025-02-10
06934184007170MultiStage®Dongguan TT Medical, Inc.KTI2025-02-10
06934184007187MultiStage®Dongguan TT Medical, Inc.KTI2025-02-10
06934184007194MultiStage®Dongguan TT Medical, Inc.KTI2025-02-10
06934184007200MultiStage®Dongguan TT Medical, Inc.KTI2025-02-10
06934184007217MultiStage®Dongguan TT Medical, Inc.KTI2025-02-10
06934184007224MultiStage®Dongguan TT Medical, Inc.KTI2025-02-10
06934184007231MultiStage®Dongguan TT Medical, Inc.KTI2025-02-10
06934184007248MultiStage®Dongguan TT Medical, Inc.KTI2025-02-10
06934184007255MultiStage®Dongguan TT Medical, Inc.KTI2025-02-10
06934184007262MultiStage®Dongguan TT Medical, Inc.KTI2025-02-10
06934184007279MultiStage®Dongguan TT Medical, Inc.KTI2025-02-10