FDA.report

Light Guard Flexible Light Handle Cover (3 Ea./pkg

Primary DI
20787551002014
Brand
Light Guard Flexible Light Handle Cover (3 Ea./pkg
Company
XODUS MEDICAL, INC.
Model
NS60513
Published
2017-05-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FTALight, surgical, accessories

Product Code Classifications

CodeDeviceSpecialtyClass
FTALight, Surgical, AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20787551002014PrimaryGS10
00787551002010Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2078755100201420787551002014
00787551002010007875510020107875510020100787551002010

GMDN Terms

TermDefinition
Medical equipment handle cover, single-use, sterileA sterile device designed specifically to cover the handle of a piece of medical equipment (e.g., operating light) to provide a physical sterile barrier between the handle and the hand of a healthcare professional, e.g., during a surgical procedure. It is typically a polymer device designed for attachment to a handle and may in addition provide grip for improved manipulation of the handle; it is not designed to cover other equipment components. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(724)337-5500info@xodusmedical.com

Regulatory Flags

DUNS number
868042664
Device count
175
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
20787551041389LPK10033 Lateral Positioning KitLPK10033LPK100332026-01-20
20787551041396LPK10034 Lateral Positioning KitLPK10034LPK100342026-01-20
2078755104010830250 Pink Pad - Loop Strap 29"30250302502025-07-16
20787551041228SPK10488 Jackson KitSPK10488SPK104882025-07-16
20787551041235PBK10008 Pegboard KitPBK10008PBK100082025-07-16
20787551041242SPK11661 Wilson Frame Positioning KitSPK11661SPK116612025-07-16
20787551041259SPK11649 Jackson Table Positioning KitSPK11649SPK116492025-07-16
20787551041266SPK11186 Surgical BackPack KitSPK11186SPK111862025-07-16
20787551041273NSCL25306 Custom Med Label PackNSCL25306NSCL253062025-07-16
20787551041280CL25257 Custom Med Label PackCL25257CL252572025-07-16
2078755103973740684 The Pink Pad XL - Advanced Trendelenburg Positioning Kit with Large DermaP40684406842025-04-16
20787551041082SPK11602 ProAxis Table KitSPK11602SPK116022025-04-16
20787551041105NSCL25293 Custom Med Label PackNSCL25293NSCL252932025-04-16
20787551041112NSCL25294 Custom Med Label PackNSCL25294NSCL252942025-04-16
2078755104112940688 XL Advanced Trendelenburg Positioning Kit - Biodegradable40688406882025-04-16
20787551041136SPK11632 Jackson KitSPK11632SPK116322025-04-16
20787551041143CL25296 Custom Med Label PackCL25296CL252962025-04-16
20787551041150SPK11639 Wilson Table KitSPK11639SPK116392025-04-16
20787551041167SPK11638 Jackson Table KitSPK11638SPK116382025-04-16
20787551041174SPK11640 Surgical BackPack KitSPK11640SPK116402025-04-16

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00748426144563Medline-MicrotekMicrotek Medical LLCFTA2026-02-18
10748426142931Skytron®Microtek Medical LLCFTA2026-02-05
10748426145024NAMicrotek Medical LLCFTA2026-02-05
00748426262700Medline-MicrotekMicrotek Medical LLCFTA2026-01-05
00724995245054HexaVueBLACK DIAMOND VIDEO, INC.FTA2025-10-17
00810008184943OlympusGyrus ACMI, LLCFTA2025-09-19
00810008185018OlympusGyrus ACMI, LLCFTA2025-09-19
00810008185032OlympusGyrus ACMI, LLCFTA2025-09-19
00810008185063OlympusGyrus ACMI, LLCFTA2025-09-19
00821925047150OlympusGyrus ACMI, LLCFTA2025-09-19
00821925047242OlympusGyrus ACMI, LLCFTA2025-09-19
00821925047259OlympusGyrus ACMI, LLCFTA2025-09-19
00821925047266OlympusGyrus ACMI, LLCFTA2025-09-19
00821925047273OlympusGyrus ACMI, LLCFTA2025-09-19
00821925047280OlympusGyrus ACMI, LLCFTA2025-09-19
00821925047297OlympusGyrus ACMI, LLCFTA2025-09-19
00821925047303OlympusGyrus ACMI, LLCFTA2025-09-19
00821925047310OlympusGyrus ACMI, LLCFTA2025-09-19
00821925047327OlympusGyrus ACMI, LLCFTA2025-09-19
00821925047365Gyrus ACMIGyrus ACMI, LLCFTA2025-09-19
05060792970658LITEXLitex Manufacturing, Inc.FTA2025-08-02
05060792971242LITEXLitex Manufacturing, Inc.FTA2025-08-02
05060792971662LITEXLitex Manufacturing, Inc.FTA2025-08-02
00560792971716LITEXLitex Manufacturing, Inc.FTA2025-08-01
05060792970009LITEXLitex Manufacturing, Inc.FTA2025-08-01
05060792970016LitexLitex Manufacturing, Inc.FTA2025-08-01
05060792970023LITEXLitex Manufacturing, Inc.FTA2025-08-01
05060792970030LITEXLitex Manufacturing, Inc.FTA2025-08-01
05060792970047LitexLitex Manufacturing, Inc.FTA2025-08-01
05060792970054LITEXLitex Manufacturing, Inc.FTA2025-08-01