FDA.report

Andorate® Bite Block (66 Fr) with Oxygen Connection & Tooth Protector

Primary DI
14897106950574
Brand
Andorate® Bite Block (66 Fr) with Oxygen Connection & Tooth Protector
Company
GA Health Company Limited
Model
GAR044F
Published
2020-08-17
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

Related Records

Product Codes

CodeName
MNKEndoscopic Bite Block

Product Code Classifications

CodeDeviceSpecialtyClass
MNKEndoscopic Bite BlockGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
14897106950574PackageGS1100In Commercial Distribution
24897106950571PackageGS1300In Commercial Distribution
04897106950577PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1489710695057414897106950574
2489710695057124897106950571
04897106950577048971069505774897106950577

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

Regulatory Flags

DUNS number
686908512
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
14897106957887andorate® 2-piece Cleaning Adapter + 3-piece Valve Kit1010492026-03-13
14897106957894andorate® 2-piece Cleaning Adapter + 4-piece Valve Kit1010502026-03-13
14897106957948andorate® 2-piece Cleaning Adapter + 3-piece Valve Kit1010692026-03-13
14897106957955andorate® 2-piece Cleaning Adapter + 4-piece Valve Kit1010702026-03-13
14897106958013andorate® 2-piece Cleaning Adapter + 3-piece Valve Kit1010952026-03-13
14897106958020andorate® 2-piece Cleaning Adapter + 4-piece Valve Kit1010962026-03-13
14897106957917andorate® 4-piece valve kit1010662026-03-12
14897106958556andorate® 4-piece valve kit1010462026-03-12
14897106958587andorate® 3-piece Valve Kit1010652026-03-12
14897106958617andorate® 4-piece valve kit1010812026-03-12
14897106958624andorate® 4-piece valve kit1010922026-03-12
14897106958631andorate®Air Water Channel Cleaning Adapter + 3-piece Valve Kit1010932026-03-12
14897106958648andorate® Air Water Channel Cleaning Adapter + 4-piece Valve Kit1010942026-03-12
14897106957979andorate® 3-piece Valve Kit1010872026-02-27
14897106958532andorate® 3-piece Valve Kit1010042026-02-27
14897106958549andorate® 3-piece Valve Kit1010372026-02-27
14897106957832Champion 3-piece valve kit1010042026-01-21
14897106957849Champion 3-piece valve kit1010372026-01-21
14897106957856Champion 4-piece valve kit1010462026-01-21
14897106957863Air Water Channel Cleaning Adapter + Champion 3-piece Valve Kit1010472026-01-21

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