FDA.reportPublic FDA data

Ethox Medical

Primary DI
20889483150037
Brand
Ethox Medical
Company
ETHOX MEDICAL, LLC
Model
950094201
Device description
Bite Block
Published
2016-09-27
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
JXLBlock, Bite

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JXLBlock, BiteNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K921946000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K921946000TUM-E-VAC BITE BLOCKEthox Corp.1992-12-09JXL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20889483150037PackageGS120In Commercial Distribution
10889483150030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088948315003720889483150037
1088948315003010889483150030

GMDN Terms#

Term, Definition table
TermDefinition
Seizure bite blockA non-sterile device inserted into a patient's mouth for the prevention of oral tissue damage (e.g., the teeth, lips, tongue and buccal mucosa) typically when the patient has convulsions (a seizure) or is undergoing an electroconvulsive therapy (ECT) that will cause nausea or can cause him/her to bite their jaws together. It will also secure a free flow for air and vomit. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00General Warehouse. Do not get wet.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-433-2797info@sun-med.com

Regulatory Flags#

DUNS number
079149179
Device count
1
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
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20889483160081EthoxVC505VC5052023-03-21
20889483160098EthoxVC510VC5102023-03-21
20889483160104EthoxVC530VC5302023-03-21
20889483149703Ethox9500890009500890002023-03-21
20889483149741Ethox9500893009500893002023-03-21
20889483149758Ethox9500894009500894002023-03-21
20889483149765Ethox9500895009500895002023-03-21
20889483149772Ethox9500896009500896002023-03-21
20889483149970Ethox9500931009500931002023-03-21
20889483149994Ethox9500935009500935002023-03-21
10889483130964Ethox Medical4500814002016-09-28
10889483131138Ethox Medical4500874002016-09-29
10889483131145Ethox Medical4500875002016-09-29
10889483150030Ethox Medical9500942012016-09-27
10889483149782Ethox Medical9500897002016-09-29
10889483084311EthoxVC405VC4052023-03-21
10889483110072EthoxVC410VC4102023-03-21
10889483110782EthoxVC430VC4302023-03-21
20889483149710Ethox9500891009500891002023-03-21
20889483149727Ethox9500892009500892002023-03-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850298007058MouthGuardSOMATICS, LLCJXL2026-05-28
00850298007034VENTIL-A Oral ProtectorSOMATICS, LLCJXL2026-05-27
00850298007041MouthGuardSOMATICS, LLCJXL2026-05-27
00860015137906PATINEUROVICE, L.L.C.JXL2025-12-19
10850045508071Cotton Bite BlockSIGMASTIM DOMESTIC, LLCJXL2025-01-27
10850045508088Cotton Bite BlockSIGMASTIM DOMESTIC, LLCJXL2025-01-27
14026704646545HUDSON RCITELEFLEX INCORPORATEDJXL2019-04-24
24026704646542HUDSON RCITELEFLEX INCORPORATEDJXL2019-04-24
14026704580221HUDSON RCITELEFLEX INCORPORATEDJXL2018-09-15
04026704580224HUDSON RCITELEFLEX INCORPORATEDJXL2018-09-15
34026704580225HUDSON RCITELEFLEX INCORPORATEDJXL2018-09-15
10889483150030Ethox MedicalETHOX MEDICAL, LLCJXL2016-09-27
M36837891GrafcoGF HEALTH PRODUCTS, INC.JXL2016-08-31