FDA.reportPublic FDA data

TIDIShield

Primary DI
00618125143580
Brand
TIDIShield
Company
TIDI PRODUCTS, LLC
Model
CFI-953
Device description
TIDIShield X-ray Cassette/Detector Covers Clear Polyethylene Sterile 11in x 14in 25 per Case
Published
2016-10-12
Public version status
Update
Distribution status
Not 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
KKXDrape, surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KKXDrape, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00618125143580PackageGS125Not in Commercial Distribution
01618125143589PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00618125143580006181251435806181251435800618125143580
01618125143589016181251435891618125143589

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
063519193
Device count
1
DM exempt
false
Premarket exempt
true
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
true
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
16975424198736Proficient SurgicalEXACT MEDICAL MANUFACTURING, INC.KKX2026-03-11
00812564036025MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
00812564036070MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
00812564036100MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
00812564036186MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
00812564036193MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
00812564036216MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
00812564036384MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10080196017010MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10888277636729MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10888277660946MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10888277660953MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10884389185780MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10888277635555MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-10
10888277357037MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-10
26975424198832Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.KKX2026-03-09
16975424199276Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.KKX2026-03-09
10193489036954MedlineMEDLINE INDUSTRIES, INC.KKX2026-02-11
10193489036961MedlineMEDLINE INDUSTRIES, INC.KKX2026-02-11
10193489036978MedlineMEDLINE INDUSTRIES, INC.KKX2026-02-11
10193489036985MedlineMEDLINE INDUSTRIES, INC.KKX2026-02-11
10193489040098MedlineMEDLINE INDUSTRIES, INC.KKX2026-02-11
20885632426299HalyardOWENS & MINOR DISTRIBUTION, INC.KKX2026-01-30
20885632426312HalyardOWENS & MINOR DISTRIBUTION, INC.KKX2026-01-30
20885632426329HalyardOWENS & MINOR DISTRIBUTION, INC.KKX2026-01-30
20885632426336HalyardOWENS & MINOR DISTRIBUTION, INC.KKX2026-01-30
20885632426343HalyardOWENS & MINOR DISTRIBUTION, INC.KKX2026-01-30
20885632426350HalyardOWENS & MINOR DISTRIBUTION, INC.KKX2026-01-30
20885632426367HalyardOWENS & MINOR DISTRIBUTION, INC.KKX2026-01-30
20885632426374HalyardOWENS & MINOR DISTRIBUTION, INC.KKX2026-01-30