DEVICE: EndoBeam™ Holmium Laser Fiber (00801741122668)

Device Identifier (DI) Information

EndoBeam™ Holmium Laser Fiber
SU0365EL
In Commercial Distribution
SU0365EL
C. R. Bard, Inc.
00801741122668
GS1

1
016898496 *Terms of Use
EndoBeam™ Holmium Laser Fiber
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
62600 General/multiple surgical laser system beam guide, single-use
A 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; a fibreoptic cable may be included with the device. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
GEX Powered laser surgical instrument
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Do not expose to organic solvents, ionizing radiation, or ultraviolet light.
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Clinically Relevant Size

[?]
Size Type Text
Length: 300 Centimeter
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Device Record Status

3948e713-dd5b-4782-9b37-db57ed557606
June 02, 2023
5
August 22, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10801741122665 3 00801741122668 In Commercial Distribution CA
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)526-4455
medical.services@crbard.com
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