Tissue Temp Probe

GUDID 37340007000653

Clinical Laserthermia Systems AB

General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system

Primary Device ID	37340007000653
NIH Device Record Key	0ef7a729-39a8-41f5-b1d4-ddff665c4358
Commercial Distribution Status	In Commercial Distribution
Brand Name	Tissue Temp Probe
Version Model Number	3001-01
Company DUNS	774856749
Company Name	Clinical Laserthermia Systems AB
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Unsafe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Operating and Storage Conditions

Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	17340007000659 [Primary]
GS1	37340007000653 [Package] Contains: 17340007000659 Package: [5 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K142216

FDA Product Code

GEX	Powered Laser Surgical Instrument

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2022-11-07
Device Publish Date	2022-10-28

On-Brand Devices [Tissue Temp Probe]

17340007000109	3203-01
17340007000093	3103-02
17340007000086	3103-01
17340007000079	3202-01
17340007000062	3102-02
17340007000055	3102-01
17340007000048	3201-01
17340007000031	3101-02
17340007000024	3101-01
37340007000721	3004-02
37340007000714	3004-01
37340007000707	3003-02
37340007000691	3003-01
37340007000684	3002-02
37340007000677	3002-01
37340007000660	3001-02
37340007000653	3001-01