ClearCam Kelling - ClearCam Kelling, Olympus Compatible, 30cm X 05mm - Clearcam Inc.

Duns Number:081499310

Device Description: ClearCam Kelling, Olympus Compatible, 30cm X 05mm X 30 degree, Version 1

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More Product Details

Catalog Number

OY3005301

Brand Name

ClearCam Kelling

Version/Model Number

1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

June 22, 2023

Issuing Agency

In HIBCC

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

Yes

Prescription Use (Rx)

Yes

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

GCJ

Product Code Name

Laparoscope, General & Plastic Surgery

Device Record Status

Public Device Record Key

d019d9e5-e197-4514-b5e2-6f2226daf724

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

June 23, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CLEARCAM INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 7