FDA.report

TIDISHIELD

Primary DI
00618125134397
Brand
TIDISHIELD
Company
TIDI PRODUCTS, LLC
Model
21107
Catalog number
21107
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
00618125134397PackageGS1500In Commercial Distribution
10618125134394PackageGS15In Commercial Distribution
01618125134396PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00618125134397006181251343976181251343970618125134397
1061812513439410618125134394
01618125134396016181251343961618125134396

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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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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