FDA.reportPublic FDA data

TruBrite Adhesive Retractor Light

Primary DI
00811331011647
Brand
TruBrite Adhesive Retractor Light
Company
Tz Medical, Inc.
Model
ARL-1010
Device description
Adhesive Retractor Light
Published
2023-10-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KYTLight, Examination, Medical, Battery Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYTLight, Examination, Medical, Battery PoweredGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811331011654PrimaryGS10
00811331011647Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811331011654008113310116548113310116540811331011654
00811331011647008113310116478113310116470811331011647

GMDN Terms#

Term, Definition table
TermDefinition
Miniature adhesive lightA small, sterile, battery-powered, torch-like device intended to be used to project a focused beam of white light during a medical/surgical procedure, after is has been fixed to an adjacent surface or device. It is typically made of polymer materials with an adhesive surface and an control button. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
793149709
Device count
10
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
true
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
00811331013610Retractor DistractorDP-72-CDR2025-02-12
00811331013634Retractor DistractorDP-74-CDL2025-02-12
00811331011227EZ HolderCT-00102023-10-20
00811331011340ARC Adjustable Radial CuffRCB-00482023-11-15
00811331011487ARC Adjustable Radial CuffRCB-00492023-11-15
00811331011500ARC Adjustable Radial CuffRCB-00472023-11-15
00811331011470ARC Adjustable Radial CuffRCB-00492023-11-15
00811331011333ARC Adjustable Radial CuffRCB-00472023-11-15
00811331013917H3R USB CableH3R-00252023-11-15
00811331013931H3R HolsterH3R-00272023-11-15
10811331010173Comfort BandCB-8514B2023-10-20
10811331010180Comfort BandCB-8517P2023-10-20
10811331010487TZ Medical Pressure Discs8880-042023-10-20
10811331013259TZ Medical Pressure Discs8880-032023-10-20
00811331010053TZ Medical Pressure Discs8880-022023-10-20
00811331011654TruBrite Adhesive Retractor LightARL-10102023-10-20
00811331011722TZ Medical Pressure Discs8880-012023-10-20
00811331011845TZ Medical Pressure Discs8880-062023-10-20
00811331013245TZ Medical Pressure Discs8880-022023-10-20
00811331011210EZ HolderCT-00102023-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00814005025650Q-OpticsQUALITY ASPIRATORS, INC.KYT2026-07-02
00814005025667Q-OpticsQUALITY ASPIRATORS, INC.KYT2026-07-02
00814005025674Q-OpticsQUALITY ASPIRATORS, INC.KYT2026-07-02
00714646001559Rechargeable Light SourceBionix, LLCKYT2025-11-22
B366LED0203PORTALEDEclerisKYT2025-11-21
10860008900361ClearSpecClearspec LLCKYT2025-10-29
20860008900368ClearSpecClearspec LLCKYT2025-10-29
00860008900364ClearSpecClearspec LLCKYT2025-10-29
00814005023526RADBL25QUALITY ASPIRATORS, INC.KYT2025-02-27
00814005023533RADBLC1QUALITY ASPIRATORS, INC.KYT2025-02-27
00814005023540RADFILM5QUALITY ASPIRATORS, INC.KYT2025-02-27
00814005023571RADHU2QUALITY ASPIRATORS, INC.KYT2025-02-27
00814005023595RADHUM4QUALITY ASPIRATORS, INC.KYT2025-02-27
00814005023618RADINST1QUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024172RADC25QUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024189RADFILM6QUALITY ASPIRATORS, INC.KYT2025-02-27
008140050242572 Pin Detachable CableQUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024288M-CZQUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024295M-ORTTL AssemblyQUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024301M-COQUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024370M-KEQUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024387M-HBQUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024394M-ORQUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024400M-QFQUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024431M-SUQUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024448M-SUTTLQUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024455M-SVQUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024462M-TTLQUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024479RADFIL1QUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024486RADFIL2QUALITY ASPIRATORS, INC.KYT2025-02-27