FDA.report

Light Guard™ Rigid Light Handle (1 Ea./pkg.)

Primary DI
20787551001963
Brand
Light Guard™ Rigid Light Handle (1 Ea./pkg.)
Company
XODUS MEDICAL, INC.
Model
60881
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
20787551001963PrimaryGS10
00787551001969Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2078755100196320787551001963
00787551001969007875510019697875510019690787551001969

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
64
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

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