FDA.reportPublic FDA data

Cotton Bite Block

Primary DI
10850045508071
Brand
Cotton Bite Block
Company
SIGMASTIM DOMESTIC, LLC
Model
9391-0003 L
Device description
MECTA ECT Cotton Bite Blocks Size Large
Published
2025-01-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
JXLBlock, Bite

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JXLBlock, BiteNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201309000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201309000ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size MediumMecta Corporation2021-06-04JXL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850045508071PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085004550807110850045508071

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
111226730
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850045508088Cotton Bite Block9391-0003 M2025-01-27
00850045508012SigmaStim Sigma9438-50012025-01-24

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
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
20889483150037Ethox MedicalETHOX MEDICAL, LLCJXL2016-09-27
M36837891GrafcoGF HEALTH PRODUCTS, INC.JXL2016-08-31