INTELLIO 4K 72205448

GUDID 00885556817155

INTELLIO 4K CCU NON-WIFI

Smith & Nephew, Inc.

Endoscope video camera
Primary Device ID00885556817155
NIH Device Record Key8e812221-54d0-4e73-8084-072844c86f67
Commercial Distribution StatusIn Commercial Distribution
Brand NameINTELLIO 4K
Version Model Number72205448
Catalog Number72205448
Company DUNS045483575
Company NameSmith & Nephew, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS100885556817155 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, general & plastic surgery

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-19
Device Publish Date2024-11-11

On-Brand Devices [INTELLIO 4K]

00885556810521INTELLIO 4K CCU WIFI US
00885556867334INTELLIO 4K CCU COUNTRY KIT EN US
00885556817155INTELLIO 4K CCU NON-WIFI

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