2540CE

GUDID 10812480010427

25 Gauge Vitreous Cutter, R1, w/ 79"/98” MID Labs Tubing Set, Sterile, Single Use

MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.

Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit
Primary Device ID10812480010427
NIH Device Record Key61274871-026a-41eb-88b8-b39cf6c6bb6d
Commercial Distribution StatusIn Commercial Distribution
Version Model Number2540CE
Catalog Number2540CE
Company DUNS790265227
Company NameMEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, 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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1(800)929-5227
Emailqa@midlabs.com
Phone1(800)929-5227
Emailqa@midlabs.com
Phone1(800)929-5227
Emailqa@midlabs.com
Phone1(800)929-5227
Emailqa@midlabs.com
Phone1(800)929-5227
Emailqa@midlabs.com
Phone1(800)929-5227
Emailqa@midlabs.com
Phone1(800)929-5227
Emailqa@midlabs.com
Phone1(800)929-5227
Emailqa@midlabs.com
Phone1(800)929-5227
Emailqa@midlabs.com
Phone1(800)929-5227
Emailqa@midlabs.com
Phone1(800)929-5227
Emailqa@midlabs.com
Phone1(800)929-5227
Emailqa@midlabs.com
Phone1(800)929-5227
Emailqa@midlabs.com
Phone1(800)929-5227
Emailqa@midlabs.com
Phone1(800)929-5227
Emailqa@midlabs.com
Phone1(800)929-5227
Emailqa@midlabs.com
Phone1(800)929-5227
Emailqa@midlabs.com

Device Dimensions

Needle Gauge25 Gauge
Needle Gauge25 Gauge
Needle Gauge25 Gauge
Needle Gauge25 Gauge
Needle Gauge25 Gauge
Needle Gauge25 Gauge
Needle Gauge25 Gauge
Needle Gauge25 Gauge
Needle Gauge25 Gauge
Needle Gauge25 Gauge
Needle Gauge25 Gauge
Needle Gauge25 Gauge
Needle Gauge25 Gauge
Needle Gauge25 Gauge
Needle Gauge25 Gauge
Needle Gauge25 Gauge
Needle Gauge25 Gauge

Operating and Storage Conditions

Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100812480010420 [Primary]
GS110812480010427 [Package]
Contains: 00812480010420
Package: Carton [6 Units]
In Commercial Distribution

FDA Product Code

HQEInstrument, Vitreous Aspiration And Cutting, Ac-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-23

Devices Manufactured by MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.

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10812480011219 - NA2021-05-05 Cannula Insertion System, 27 Gauge, Sterile, Single Step, Generic, w/ Tubing Set
10812480011233 - NA2021-05-05 Cannula Insertion System, 25 Gauge, Sterile, Single Step, Generic, w/ Tubing Set
10812480011257 - NA2021-05-05 Cannula Insertion System, 23 Gauge, Sterile, Single Step, Generic, w/ Tubing Set
10812480011028 - Bi-Blade®2018-12-17 25 Gauge BB Vitreous Cutter, R1+, w/ 79” Anterior Tubing Set, Sterile, Single Use, 1ea
10812480011042 - Bi-Blade®2018-12-17 27 Gauge BB Vitreous Cutter, R4+, w/ 72” Anterior Tubing Set, Sterile, Single Use
10812480011196 - Bi-Blade®2018-12-17 27 Gauge BB Vitreous Cutter, R3A, w/ 72” Anterior Tubing Set, Sterile, Single Use

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