1.15 mm Zero-T punch - 1.15 mm Zero-T punch - Cole Instruments Inc

Duns Number:078573265

Device Description: 1.15 mm Zero-T punch

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More Product Details

Catalog Number

119.115

Brand Name

1.15 mm Zero-T punch

Version/Model Number

IHTI-1.15-2S-094-V1 punch

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"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

LRY

Product Code Name

Punch, Surgical

Device Record Status

Public Device Record Key

25782f0b-4445-41e7-a5b6-5df873f7bc9a

Public Version Date

February 12, 2021

Public Version Number

1

DI Record Publish Date

February 04, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"COLE INSTRUMENTS INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 75