FDA.reportPublic FDA data

TIDISHIELD

Primary DI
00618125134267
Brand
TIDISHIELD
Company
TIDI PRODUCTS, LLC
Model
21103
Catalog number
21103
Device description
TIDISHIELD Curing Light Sleeve
Published
2016-10-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
PEMDental Barriers And Sleeves

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PEMDental Barriers And SleevesGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00618125134267PackageGS1500In Commercial Distribution
10618125134264PackageGS15In Commercial Distribution
01618125134266PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00618125134267006181251342676181251342670618125134267
1061812513426410618125134264
01618125134266016181251342661618125134266

GMDN Terms#

Term, Definition table
TermDefinition
Instrument/equipment drape, single-use, non-sterileA non-sterile device made of natural and/or synthetic flexible materials intended to be used as a non-dedicated protective covering for various instruments/equipment (e.g., dental chairs, treatment tables), to provide a barrier against cross-contamination in the home or healthcare facility. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
063519193
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00618125134724Grip-Lok3300M-NSB3300M-NSB2022-10-18
10618125192325POSEY8334WL8334WL2025-12-04
10618125192318AquaGuard50000-SMP50000-SMP2025-09-23
20618125192308Carina570-5439570-54392025-09-22
10618125187123VALO466846682025-08-29
10618125187130VALO466746672025-08-29
10618125187147VALO466646662025-08-29
80618125188716VALO100636610063662025-08-29
80618125188723VALO100636710063672025-08-29
80618125188730VALO100636810063682025-08-29
10618125189950VALO466946692025-08-29
80618125190177VALO100980810098082025-08-29
10618125190185VALO466546652025-08-29
20618125114669Sirona20809B63101202025-07-10
10618125192264Steris31780BF458 (056404-710)2025-07-01
10618125192271Steris31780 N/SBF459 (056404-709)2025-07-01
20618125192254Posey806080602024-12-23
00618125192144Grip-Lok3300MWA-10PK3300MWA-10PK2024-12-02
00618125192175Grip-Lok3400LFC-10PK3400LFC-10PK2024-12-02
00618125192182Grip-Lok3400L-10PK3400L-10PK2024-12-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D125100B2Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D125100C2Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251012Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251022Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251032Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D125104L2Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D125104S2Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251062Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251072Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251082Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251092Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251112Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251122Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251132Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251142Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251182Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251192Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D125123L2Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D125123M2Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D125123S2Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D125123SS2Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D125123XL2Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251252Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D125125SS2Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251282Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251292Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D125133L2Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D125133S2Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D125135L2Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D125135S2Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22