Ambler Surgical - Simcoe irrigation-aspiration cannula, 23 gauge - AMBLER SURGICAL CORP.

Duns Number:015272206

Device Description: Simcoe irrigation-aspiration cannula, 23 gauge thin-wall, curved right, U-shaped tip, 0.3m Simcoe irrigation-aspiration cannula, 23 gauge thin-wall, curved right, U-shaped tip, 0.3mm anterior aspiration port, supplied with 10'' of tubing and luer-lock adapter, 15.0mm overall length excluding hub

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More Product Details

Catalog Number

1228E

Brand Name

Ambler Surgical

Version/Model Number

Simcoe irrigation-aspiration cannula

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)

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

HMX

Product Code Name

Cannula, ophthalmic

Device Record Status

Public Device Record Key

26b2e8e8-5882-4d7a-af04-1d4e8a9a8372

Public Version Date

January 12, 2021

Public Version Number

1

DI Record Publish Date

January 04, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AMBLER SURGICAL CORP." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 14984
2 A medical device with a moderate to high risk that requires special controls. 3118