FDA.report

HB-365-TR-PL

Primary DI
00816469020554
Brand
HB-365-TR-PL
Company
LASER PERIPHERALS, LLC
Model
HB-365-TR-PL
Catalog number
HB-365-TR-PL
Device description
365u TR Compatible Laser Fiber PL
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
GEXPowered laser surgical instrument

Product Code Classifications

CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00816469020554PrimaryGS10

GMDN Terms

TermDefinition
Urogenital surgical laser system beam guide, single-useA sterile, flexible, probe-like device intended to be connected to a surgical laser system to invasively direct and deliver laser energy for urogenital surgical applications, typically to haemostatically cut, coagulate, and vaporize prostate tissue to treat benign prostatic hyperplasia (BPH), and/or to treat bladder, urethral, and ureteral conditions (e.g., tumours, condylomas); it is not intended for other surgical applications. It is typically made of fibreoptic materials or fused silica and contains an invasive laser-firing distal end which may be available in a variety of configurations. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
177234754
Device count
1
DM exempt
true
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
false

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00816469021674LG-200-CNLG-200-CNLG-200-CN2024-12-06
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00816469021667LG-T200-PLLG-T200-PLLG-T200-PL2024-07-15
00816469021629DBSS-272DBSS-272DBSS-2722022-05-22
00816469021636DBSS-272-PLDBSS-272-PLDBSS-272-PL2022-05-22
00816469021612DB-600R-5DB-600R-5DB-600R-52021-11-19
00816469021599HTB-800HTB-800HTB-8002021-03-22
00816469021605HTB-800-PLHTB-800-PLHTB-800-PL2021-03-22
00816469021582DB-600R-HPT-PLDB-600R-HPT-PLDB-600R-HPT-PL2020-09-21
00816469021537LG-272-N-PL-MLG-272-N-PL-MLG-272-N-PL-M2020-08-10
00816469021544LG-365-E-PL-MLG-365-E-PL-MLG-365-E-PL-M2020-08-10
00816469021551LG-550-E-PL-MLG-550-E-PL-MLG-550-E-PL-M2020-08-10
00816469021568RTB-272-PL-MRTB-272-PL-MRTB-272-PL-M2020-08-10
00816469021575RB-365-PL-MRB-365-PL-MRB-365-PL-M2020-08-10
00816469021520LG-272-N-PLLG-272-N-PLLG-272-N-PL2020-01-10
00816469021414FC-001FC-001FC-0012019-12-02
00816469021421FC-002 ACFC-002 ACFC-002 AC2019-12-02
00816469021438FS-272FS-272FS-2722019-12-02
00816469021445FS-365FS-365FS-3652019-12-02

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