Insufflation Needle 0600-6150-000

GUDID 10817984010669

Insufflation Needle 150MM

MECTRA LABS, INC.

Spring-loaded pneumoperitoneum needle, single-use Spring-loaded pneumoperitoneum needle, single-use
Primary Device ID10817984010669
NIH Device Record Keydf067064-74bc-47c9-b975-bad0173c09fa
Commercial Distribution Discontinuation2020-01-10
Commercial Distribution StatusNot in Commercial Distribution
Brand NameInsufflation Needle
Version Model Number0600-6150-000
Catalog Number0600-6150-000
Company DUNS606939072
Company NameMECTRA LABS, INC.
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)323-3968
Emailmectrasales@mectralabs.com
Phone+1(800)323-3968
Emailmectrasales@mectralabs.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 20 Degrees Fahrenheit and 115 Degrees Fahrenheit
Handling Environment TemperatureBetween 20 Degrees Fahrenheit and 115 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100817984010662 [Primary]
GS110817984010669 [Package]
Contains: 00817984010662
Package: Inner pack [10 Units]
Discontinued: 2020-01-10
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HIFINSUFFLATOR, LAPAROSCOPIC

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-01-13
Device Publish Date2019-01-25

On-Brand Devices [Insufflation Needle]

10817984010669Insufflation Needle 150MM
10817984010652Insufflation Needle 120MM

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.