FDA.reportPublic FDA data

SCOPE SAVER

Primary DI
30653405050289
Brand
SCOPE SAVER
Company
Conmed Corporation
Model
000429
Catalog number
000429
Device description
CONMED Scope Saver Bite Block, 20x27mm
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
KTIBRONCHOSCOPE ACCESSORY

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30653405050289PackageGS150In Commercial Distribution
20653405050282PrimaryGS10
00653405050288Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3065340505028930653405050289
2065340505028220653405050282
00653405050288006534050502886534050502880653405050288

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
071595540
Device count
50
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
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

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Primary DI, Brand, Company table
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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
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