Medline - LAPAROSCOPE, TELESCOPE, 10MM, 30DEG,30CM - MEDLINE INDUSTRIES, INC.

Duns Number:025460908

Device Description: LAPAROSCOPE, TELESCOPE, 10MM, 30DEG,30CM

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More Product Details

Catalog Number

MDG7101030

Brand Name

Medline

Version/Model Number

MDG7101030

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K060233

Product Code Details

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Device Record Status

Public Device Record Key

ff6f0dbb-8d69-4c9a-a884-a6e492236b2d

Public Version Date

February 03, 2022

Public Version Number

1

DI Record Publish Date

January 26, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDLINE INDUSTRIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 38540
2 A medical device with a moderate to high risk that requires special controls. 85094
3 A medical device with high risk that requires premarket approval 2
U Unclassified 7