FDA.report

EndoBeam™ Holmium Laser Fiber

Primary DI
00801741122255
Brand
EndoBeam™ Holmium Laser Fiber
Company
C. R. Bard, Inc.
Model
RU0365
Catalog number
RU0365
Device description
EndoBeam™ Holmium Laser Fiber
Published
2016-09-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GEXPowered laser surgical instrument

Product Code Classifications

CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00801741122255PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00801741122255008017411222558017411222550801741122255

GMDN Terms

TermDefinition
General/multiple surgical laser system beam guide, reusableA surgical device intended to be connected to a general/multiple surgical laser system to invasively direct and deliver laser energy for multiple different surgical applications (non-dedicated), which may include vaporization, ablation, coagulation, haemostasis, excision, resection, incision of soft and cartilaginous tissue, and/or fragmentation of urinary and biliary calculi. It is typically a probe-, handpiece-, or tip-like device which includes fibreoptic materials. This is a reusable device intended to be sterilized prior to use.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Do not expose to organic solvents, ionizing radiation, or ultraviolet light.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)526-4455medical.services@crbard.com

Regulatory Flags

DUNS number
016898496
Device count
1
DM exempt
false
Premarket exempt
false
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
true

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