Speculum Tubing

GUDID 00817688021407

I.C. MEDICAL, INC.

Surgical plume evacuation system tube
Primary Device ID00817688021407
NIH Device Record Key4f274d32-977d-453f-a3b9-c929a4a59d74
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpeculum Tubing
Version Model NumberICM-000-0365
Company DUNS616182895
Company NameI.C. MEDICAL, 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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100817688021391 [Primary]
GS100817688021407 [Package]
Contains: 00817688021391
Package: [9 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00817688021407]

Ethylene Oxide


[00817688021407]

Ethylene Oxide


[00817688021407]

Ethylene Oxide


[00817688021407]

Ethylene Oxide


[00817688021407]

Ethylene Oxide


[00817688021407]

Ethylene Oxide


[00817688021407]

Ethylene Oxide


[00817688021407]

Ethylene Oxide


[00817688021407]

Ethylene Oxide


[00817688021407]

Ethylene Oxide


[00817688021407]

Ethylene Oxide


[00817688021407]

Ethylene Oxide


[00817688021407]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-04-08
Device Publish Date2016-09-24

On-Brand Devices [Speculum Tubing]

008176880214212195
00817688021407ICM-000-0365
00817688021384ICM-000-0027
00817688021360ICM-000-0021
00817688022947Speculum Tubing, 22mm to 10mm Connector, Sterile

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