FDA.report

Adult Bite Block

Primary DI
10677964060684
Brand
Adult Bite Block
Company
MEDIVATORS INC.
Model
100411
Published
2021-03-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
10677964060684PackageGS150In Commercial Distribution
20677964060681PackageGS12In Commercial Distribution
00677964060687PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1067796406068410677964060684
2067796406068120677964060681
00677964060687006779640606876779640606870677964060687

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(800)548-4873custserv@medivators.com

Regulatory Flags

DUNS number
068199363
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
true
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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