FDA.reportPublic FDA data

HUDSON RCI

Primary DI
24026704580136
Brand
HUDSON RCI
Company
TELEFLEX INCORPORATED
Model
IPN041674
Catalog number
1140
Device description
BiteGard Oral Bite Block
Published
2018-09-15
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

Related Records

Contact Domains

Product Codes

CodeName
MNKEndoscopic bite block

Product Code Classifications

CodeDeviceSpecialtyClass
MNKEndoscopic Bite BlockGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
24026704580136PackageGS150Not in Commercial Distribution
04026704580132PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
2402670458013624026704580136
04026704580132040267045801324026704580132

GMDN Terms

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

Contacts

PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags

DUNS number
002348191
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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06926839800595AnreiAnrei Medical(HZ) Co.,Ltd.MNK2025-01-07
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