NDS

GUDID 04961333244065

42" RADIANCE G2 LED WITH SINGLE FIBER

PENTAX OF AMERICA, INC.

Endoscopic video image display monitor

• Primary Device ID: 04961333244065
• NIH Device Record Key: 21d56a90-1514-4586-b8d7-7fc4aeda2b45
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NDS
• Version Model Number: NDS90R0070
• Company DUNS: 083211284
• Company Name: PENTAX OF AMERICA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Length: 42 Inch
• Length: 42 Inch
• Length: 42 Inch
• Length: 42 Inch
• Length: 42 Inch
• Length: 42 Inch
• Length: 42 Inch
• Length: 42 Inch
• Length: 42 Inch
• Length: 42 Inch
• Length: 42 Inch
• Length: 42 Inch
• Length: 42 Inch
• Length: 42 Inch
• Length: 42 Inch
• Length: 42 Inch
• Length: 42 Inch
• Length: 42 Inch
• Length: 42 Inch
• Length: 42 Inch
• Length: 42 Inch
• Length: 42 Inch
• Length: 42 Inch
• Length: 42 Inch
• Length: 42 Inch
• Length: 42 Inch
• Length: 42 Inch
• Length: 42 Inch
• Length: 42 Inch
• Length: 42 Inch
• Length: 42 Inch
• Length: 42 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	04961333244065 [Primary]

FDA Product Code

• KQM: Camera, Surgical And Accessories

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-04-16
• Device Publish Date: 2018-03-15

On-Brand Devices [NDS]

• 04961333244539: NDS 32" LED DISPLAY, W/O FIBER
• 04961333244522: RADIANCE 55" G2 LED, W/SINGLE FIBER
• 04961333244126: NDS CONDUCTOR G2 BASE UNIT(HD STRM INCL)
• 04961333244119: ZWIRE G2 ACC. RADI. ULTRA 27 (SNGL)
• 04961333244102: ZWIRE G2 ACC. RADI. ULTRA 27 (PAIR)
• 04961333244096: 27" RADIANCE ULTRA MONITOR
• 04961333244089: ZEROWIRE G2 PAIR (RX & TX)
• 04961333244072: NDS RADIANCE ULTRA 32" ANALOG MONITOR
• 04961333244065: 42" RADIANCE G2 LED WITH SINGLE FIBER
• 04961333244058: RADIANCE 24" G2 W/SINGLE FIBER
• 04961333244041: NDS 21" ENDOVUE DISPLAY
• 04961333244034: NDS 21" ENDOVUE DISPLAY
• 04961333244027: NATIONAL DISPLAY 26" RADIANCE HD LED MON
• 04961333244010: NDS 24" LED MONITOR
• 04961333244003: NDS 24" ENDOVUE MONITOR
• 04961333243280: NDS CONDUCTOR VIDEO SWITCHING PACKAGE
• 04961333240906: NDS 19IN RADIANCE HD MONITOR MED GRADE
• 04961333240739: POWER SUPPLY-NDS 23" AND 32" MONITOR
• 04961333240722: POWER SUPPLY- NDS 26" LED MONITOR