ZeroWire G2

GUDID 00818089022796

DePuy Synthes, ZeroWire G2 Receiver Only

NDS SURGICAL IMAGING, LLC

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• Primary Device ID: 00818089022796
• NIH Device Record Key: 3dc8174b-a694-40fa-8560-dde2b5f2cad0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZeroWire G2
• Version Model Number: 90T2111
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818089022796 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151609

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

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: 2021-10-21
• Device Publish Date: 2021-10-13

Devices Manufactured by NDS SURGICAL IMAGING, LLC

• 00818089022925 - EndoVue: 2022-02-14 SMITH & NEPHEW, ENDOVUE PLUS 4K 32", QUAD-LINK SDI, AMERICA, JAPAN, BC-WK32-A1B20
• 00851455007812 - Radiance: 2022-02-14 DEPUY SYNTHES, ROW, RADIANCE ULTRA 32" 4K, 4X SDI, SC-WK32-G1B24
• 00851455007836 - Radiance: 2022-02-14 DEPUY SYNTHES, ROW, RADIANCE ULTRA 32" 4K, 4X SDI, SC-WK32-G1B24
• 00818089022642 - Radiance: 2021-12-23 PENTAX, RADIANCE ULTRA 32", ANALOG SECONDARY, SC-WU32-G1522
• 00818089022673 - Radiance: 2021-12-23 RADIANCE ULTRA 32" 4K, 4X SDI, SC-WK32-G1B24
• 00818089022772 - Radiance: 2021-12-23 Smith & Nephew, RADIANCE ULTRA 32" 4K, 4X SDI, SC-WK32-G1B24
• 00818089022789 - Radiance: 2021-10-21 DePuy Synthes, ZeroWire G2 Transmitter & Receiver Kit
• 00818089022796 - ZeroWire G2: 2021-10-21DePuy Synthes, ZeroWire G2 Receiver Only
• 00818089022796 - ZeroWire G2: 2021-10-21 DePuy Synthes, ZeroWire G2 Receiver Only