MectaPlug 01.33.001

GUDID 03760177041295

TEKNIMED

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Primary Device ID03760177041295
NIH Device Record Key154e9ade-4783-4d38-909f-d22312b7c753
Commercial Distribution Discontinuation2022-09-30
Commercial Distribution StatusNot in Commercial Distribution
Brand NameMectaPlug
Version Model NumberDiameter 08
Catalog Number01.33.001
Company DUNS764746723
Company NameTEKNIMED
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 Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Outer Diameter8 Millimeter
Outer Diameter8 Millimeter
Outer Diameter8 Millimeter
Outer Diameter8 Millimeter
Outer Diameter8 Millimeter
Outer Diameter8 Millimeter
Outer Diameter8 Millimeter
Outer Diameter8 Millimeter
Outer Diameter8 Millimeter
Outer Diameter8 Millimeter
Outer Diameter8 Millimeter
Outer Diameter8 Millimeter
Outer Diameter8 Millimeter
Outer Diameter8 Millimeter
Outer Diameter8 Millimeter
Outer Diameter8 Millimeter
Outer Diameter8 Millimeter
Outer Diameter8 Millimeter
Outer Diameter8 Millimeter
Outer Diameter8 Millimeter
Outer Diameter8 Millimeter
Outer Diameter8 Millimeter
Outer Diameter8 Millimeter
Outer Diameter8 Millimeter
Outer Diameter8 Millimeter
Outer Diameter8 Millimeter
Outer Diameter8 Millimeter
Outer Diameter8 Millimeter
Outer Diameter8 Millimeter
Outer Diameter8 Millimeter
Outer Diameter8 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS103760177041295 [Primary]

FDA Product Code

LZNCement Obturator

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2022-10-03
Device Publish Date2015-10-16

On-Brand Devices [MectaPlug]

03760177044029Diameter 14
03760177041332Diameter 18
03760177041325Diameter 16
03760177041318Diameter 12
03760177041301Diameter 10
03760177041295Diameter 08

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