FDA.report

TIDISHIELD

Primary DI
00618125134243
Brand
TIDISHIELD
Company
TIDI PRODUCTS, LLC
Model
21101
Catalog number
21101
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
00618125134243PackageGS1500In Commercial Distribution
10618125134240PackageGS15In Commercial Distribution
01618125134242PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00618125134243006181251342436181251342430618125134243
1061812513424010618125134240
01618125134242016181251342421618125134242

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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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
00618125192199Grip-Lok3300M-10PK3300M-10PK2024-12-02

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06430035873388OCCLUSAL 4C REFILL KITPaloDEx Group OyPEM2025-12-23
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10618125189950VALOTIDI PRODUCTS, LLCPEM2025-08-29
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00840456202616JMUJMU DENTAL, INCPEM2025-06-17
00840456207116JMUJMU DENTAL, INCPEM2025-06-17
00840456209042JMUJMU DENTAL, INCPEM2025-06-17
00840456209059JMUJMU DENTAL, INCPEM2025-06-17
00840456209066JMUJMU DENTAL, INCPEM2025-06-17
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