FDA.reportPublic FDA data

Light Guard™ Rigid Light Handle (2 Ea./pkg.)

Primary DI
20787551001970
Brand
Light Guard™ Rigid Light Handle (2 Ea./pkg.)
Company
XODUS MEDICAL, INC.
Model
60882
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FTALight, surgical, accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTALight, Surgical, AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20787551001970PrimaryGS10
00787551001976Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2078755100197020787551001970
00787551001976007875510019767875510019760787551001976

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(724)337-5500info@xodusmedical.com

Regulatory Flags#

DUNS number
868042664
Device count
40
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 DI, Brand, Model table
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

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