FDA.report

TIDISHIELD

Primary DI
00618125134281
Brand
TIDISHIELD
Company
TIDI PRODUCTS, LLC
Model
21105
Catalog number
21105
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

Related Records

Product Codes

CodeName
PEMDental Barriers And Sleeves

Product Code Classifications

CodeDeviceSpecialtyClass
PEMDental Barriers And SleevesGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00618125134281PackageGS1500In Commercial Distribution
10618125134288PackageGS15In Commercial Distribution
01618125134280PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00618125134281006181251342816181251342810618125134281
1061812513428810618125134288
01618125134280016181251342801618125134280

GMDN Terms

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

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

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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

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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