Insufflator

GUDID 06971381251357

The insufflator is intended to form and maintain the pneumoperitoneum in laparoscopic surgery to provide visual field and operating space.

SCIVITA MEDICAL TECHNOLOGY CO., LTD.

Laparoscopic insufflator
Primary Device ID06971381251357
NIH Device Record Key16c2c72b-255f-4f33-b768-8e5f4d6e7957
Commercial Distribution StatusIn Commercial Distribution
Brand NameInsufflator
Version Model NumberSL101
Company DUNS544519831
Company NameSCIVITA MEDICAL TECHNOLOGY CO., LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106971381251357 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HIFInsufflator, Laparoscopic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-07
Device Publish Date2024-02-28

On-Brand Devices [Insufflator]

06971381251364The insufflator is intended to form and maintain the pneumoperitoneum in laparoscopic surgery to
06971381251357The insufflator is intended to form and maintain the pneumoperitoneum in laparoscopic surgery to

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