RADIANCE

GUDID 00818089020228

RADIANCE ULTRA 32", TRUCOLOR, ANALOG SECONDARY, SC-WU32-G1522

NDS SURGICAL IMAGING, LLC

Image display monitor, colour

• Primary Device ID: 00818089020228
• NIH Device Record Key: d6a69ea0-dd2a-49b8-b053-c0252f5ea776
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RADIANCE
• Version Model Number: 90R0113
• Company DUNS: 959691940
• Company Name: NDS SURGICAL IMAGING, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-408-776-0085
• Email: info@ndssi.com
• Phone: 1-408-776-0085
• Email: info@ndssi.com
• Phone: 1-408-776-0085
• Email: info@ndssi.com
• Phone: 1-408-776-0085
• Email: info@ndssi.com
• Phone: 1-408-776-0085
• Email: info@ndssi.com
• Phone: 1-408-776-0085
• Email: info@ndssi.com
• Phone: 1-408-776-0085
• Email: info@ndssi.com
• Phone: 1-408-776-0085
• Email: info@ndssi.com
• Phone: 1-408-776-0085
• Email: info@ndssi.com
• Phone: 1-408-776-0085
• Email: info@ndssi.com
• Phone: 1-408-776-0085
• Email: info@ndssi.com
• Phone: 1-408-776-0085
• Email: info@ndssi.com
• Phone: 1-408-776-0085
• Email: info@ndssi.com
• Phone: 1-408-776-0085
• Email: info@ndssi.com
• Phone: 1-408-776-0085
• Email: info@ndssi.com
• Phone: 1-408-776-0085
• Email: info@ndssi.com
• Phone: 1-408-776-0085
• Email: info@ndssi.com
• Phone: 1-408-776-0085
• Email: info@ndssi.com
• Phone: 1-408-776-0085
• Email: info@ndssi.com
• Phone: 1-408-776-0085
• Email: info@ndssi.com
• Phone: 1-408-776-0085
• Email: info@ndssi.com
• Phone: 1-408-776-0085
• Email: info@ndssi.com
• Phone: 1-408-776-0085
• Email: info@ndssi.com
• Phone: 1-408-776-0085
• Email: info@ndssi.com
• Phone: 1-408-776-0085
• Email: info@ndssi.com
• Phone: 1-408-776-0085
• Email: info@ndssi.com
• Phone: 1-408-776-0085
• Email: info@ndssi.com
• Phone: 1-408-776-0085
• Email: info@ndssi.com
• Phone: 1-408-776-0085
• Email: info@ndssi.com
• Phone: 1-408-776-0085
• Email: info@ndssi.com
• Phone: 1-408-776-0085
• Email: info@ndssi.com
• Phone: 1-408-776-0085
• Email: info@ndssi.com
• Phone: 1-408-776-0085
• Email: info@ndssi.com
• Phone: 1-408-776-0085
• Email: info@ndssi.com
• Phone: 1-408-776-0085
• Email: info@ndssi.com
• Phone: 1-408-776-0085
• Email: info@ndssi.com
• Phone: 1-408-776-0085
• Email: info@ndssi.com
• Phone: 1-408-776-0085
• Email: info@ndssi.com
• Phone: 1-408-776-0085
• Email: info@ndssi.com
• Phone: 1-408-776-0085
• Email: info@ndssi.com
• Phone: 1-408-776-0085
• Email: info@ndssi.com
• Phone: 1-408-776-0085
• Email: info@ndssi.com
• Phone: 1-408-776-0085
• Email: info@ndssi.com
• Phone: 1-408-776-0085
• Email: info@ndssi.com
• Phone: 1-408-776-0085
• Email: info@ndssi.com
• Phone: 1-408-776-0085
• Email: info@ndssi.com
• Phone: 1-408-776-0085
• Email: info@ndssi.com
• Phone: 1-408-776-0085
• Email: info@ndssi.com
• Phone: 1-408-776-0085
• Email: info@ndssi.com
• Phone: 1-408-776-0085
• Email: info@ndssi.com
• Phone: 1-408-776-0085
• Email: info@ndssi.com
• Phone: 1-408-776-0085
• Email: info@ndssi.com
• Phone: 1-408-776-0085
• Email: info@ndssi.com
• Phone: 1-408-776-0085
• Email: info@ndssi.com
• Phone: 1-408-776-0085
• Email: info@ndssi.com
• Phone: 1-408-776-0085
• Email: info@ndssi.com
• Phone: 1-408-776-0085
• Email: info@ndssi.com
• Phone: 1-408-776-0085
• Email: info@ndssi.com
• Phone: 1-408-776-0085
• Email: info@ndssi.com
• Phone: 1-408-776-0085
• Email: info@ndssi.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818089020228 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161228

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-06

On-Brand Devices [RADIANCE]

• 00818089020785: PENTAX, ZEROWIRE G2 DUO, DVI, SDI, FOR 32”
• 00818089020778: PENTAX, ZEROWIRE G2 TX, DVI, SDI, WT-P42-13 FOR 32”
• 00818089020761: PENTAX, ZEROWIRE G2 RX, DVI, WR-P42-11 FOR 32”
• 00818089020754: PENTAX, ZEROWIRE G2 TX, DVI, SDI, WT-P42-13, FOR 27”
• 00818089020747: PENTAX, ZEROWIRE G2 RX, DVI, WR-P42-11, FOR 27”
• 00818089020730: PENTAX, ZEROWIRE G2 DUO, DVI, SDI, FOR 27”
• 00818089020723: CUSTOM FUJIFILM, 32" RADIANCE G2, W/O FIBER, SC-WU32-A1511
• 00818089020716: CUSTOM PENTAX, 32" RADIANCE G2, W/O FIBER, SC-WU32-A1511
• 00818089020709: RADIANCE G2 24", W/ 4-FIBER, CUSTOM KARL STORZ US, SC-WU24-A1515
• 00818089020693: CUSTOM FUJIFILM US, 24" RADIANCE G2, W/O FIBER, SC-WU24-A1511
• 00818089020686: CUSTOM PENTAX US, 24" RADIANCE G2, W/O FIBER, SC-WU24-A1511
• 00818089020679: CUSTOM KARL STORZ US, 24" RADIANCE G2, W/ SC SINGLE FIBER, SC-WU24-A1515
• 00818089020655: CUSTOM NOVADAQ, 26" RADIANCE G2 HB, W/O FIBER, SC-WU26-A1511
• 00818089020648: CUSTOM SMITH & NEPHEW, 26" RADIANCE G2 HB, W/O FIBER, SC-WU26-A1511
• 00818089020631: CUSTOM FUJIFILM, 26" RADIANCE G2 HB, W/O FIBER, SC-WU26-A1511
• 00818089020624: CUSTOM OLYMPUS, 26" RADIANCE G2 HB, W/O FIBER, SC-WU26-A1511
• 00818089020617: CUSTOM WOLF US, 26" RADIANCE G2 HB, W/O FIBER, SC-WU26-A1511
• 00818089020600: CUSTOM PENTAX, 26" RADIANCE G2 HB, W/O FIBER, SC-WU26-A1511
• 00818089020594: CUSTOM KARL STORZ US, 26" RADIANCE G2, W/ SINGLE FIBER, SC-WU26-A1515
• 00818089020587: CUSTOM KARL STORZ US, 26" RADIANCE G2, W/O FIBER, SC-WU26-A1511
• 00818089020570: RADIANCE 19", FULL MMI, CUSTOM FUJIFILM US, SC-SX19-A1511
• 00818089020563: RADIANCE 19", FULL MMI, CUSTOM KARL STORZ US, SC-SX19-A1511
• 00818089020556: RADIANCE 19", FULL MMI, CUSTOM PENTAX, SC-SX19-A1511
• 00818089020549: RADIANCE 19", W/DVI-R, PIP, FULL MMI, CUSTOM OLYMPUS, SC-SX19-A1511
• 00818089020532: RADIANCE G3, 26", WITH SINGLE FIBER, SC-WU26-A1515
• 00818089020525: RADIANCE G3, 26", SC-WU26-A1511
• 00818089020518: RADIANCE G2 32", W/ SINGLE FIBER, SC-WU32-A1515
• 00818089020501: RADIANCE G2 24", W/ SINGLE FIBER, W/ TOUCH, SC-WU24-R1515
• 00818089020495: RADIANCE G2 24", W/O FIBER, W/ TOUCH, SC-WU24-R1511
• 00818089020488: RADIANCE D HB, 26", SC-WU26-A1507 (US/ROW)
• 00818089020426: RADIANCE G2, 42" full MMI w/fiber
• 00818089020389: RADIANCE ULTRA 27" w/SECONDARY DIGITAL BOARD
• 00818089020242: RADIANCE ULTRA 32" 4K, 4X SDI, SC-WK32-G1B24
• 00818089020235: RADIANCE ULTRA 32", TRUCOLOR, PRIMARY ONLY, SC-WU32-G1507
• 00818089020228: RADIANCE ULTRA 32", TRUCOLOR, ANALOG SECONDARY, SC-WU32-G1522
• 00818089020211: RADIANCE ULTRA 32", TRUCOLOR, DIGITAL SECONDARY, SC-WU32-G1520
• 00818089020204: RADIANCE ULTRA 32", PRIMARY ONLY, SC-WU32-G1507
• 00818089020198: RADIANCE ULTRA 32", ANALOG SECONDARY, SC-WU32-G1522
• 00818089020181: RADIANCE ULTRA 32", DIGITAL SECONDARY, SC-WU32-G1520
• 00818089020174: RADIANCE ULTRA 27", PRIMARY ONLY, SC-WU27-G1507
• 00818089020167: RADIANCE ULTRA 27", ANALOG SECONDARY, SC-WU27-G1522
• 00818089022611: RADIANCE ULTRA 32" 4K, PRIMARY BOARD ONLY, 2D, SC-WK32-G1B00, S+N
• 00818089022833: TITAN, Radiance Ultra 4K 3D 32", 1 Meter
• 00818089022789: DePuy Synthes, ZeroWire G2 Transmitter & Receiver Kit
• 00818089022772: Smith & Nephew, RADIANCE ULTRA 32" 4K, 4X SDI, SC-WK32-G1B24
• 00818089022673: RADIANCE ULTRA 32" 4K, 4X SDI, SC-WK32-G1B24
• 00818089022642: PENTAX, RADIANCE ULTRA 32", ANALOG SECONDARY, SC-WU32-G1522
• 00851455007836: DEPUY SYNTHES, ROW, RADIANCE ULTRA 32" 4K, 4X SDI, SC-WK32-G1B24
• 00851455007812: DEPUY SYNTHES, ROW, RADIANCE ULTRA 32" 4K, 4X SDI, SC-WK32-G1B24