FDA.reportPublic FDA data

PATI

Primary DI
00860015137906
Brand
PATI
Company
NEUROVICE, L.L.C.
Model
1A
Published
2025-12-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K221469000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221469000PATI (Protector Against Tongue Injury)Neurovice, LLC2023-02-22JXL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860015137906PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860015137906008600151379068600151379060860015137906

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

Contacts#

Phone, Email table
PhoneEmail
(844) 844-7284support@neurovice.org

Regulatory Flags#

DUNS number
080731028
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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