Ambler Surgical - Anterior chamber rycroft cannula, 20 gauge x - AMBLER SURGICAL CORP.

Duns Number:015272206

Device Description: Anterior chamber rycroft cannula, 20 gauge x 4.0mm, angled tip, packaged individually, ste Anterior chamber rycroft cannula, 20 gauge x 4.0mm, angled tip, packaged individually, sterile, disposable, box of 10 * * SPECIAL ORDER PRODUCT - MINIMUM ORDER OF 20 BOXES AND 4-6 WEEK LEAD TIME * *

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More Product Details

Catalog Number

121281

Brand Name

Ambler Surgical

Version/Model Number

Anterior chamber rycroft 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

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

HMX

Product Code Name

Cannula, ophthalmic

Device Record Status

Public Device Record Key

a6552849-709e-4853-a18e-2f1c38722298

Public Version Date

January 12, 2021

Public Version Number

1

DI Record Publish Date

January 04, 2021

Additional Identifiers

Package DI Number

00190660198565

Quantity per Package

10

Contains DI Package

10190660198562

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX

"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