Ambler Surgical - Atkinson retrobulbar anesthesia needle, 23 gauge - AMBLER SURGICAL CORP.

Duns Number:015272206

Device Description: Atkinson retrobulbar anesthesia needle, 23 gauge x 1 1/2'', straight, packaged individuall Atkinson retrobulbar anesthesia needle, 23 gauge x 1 1/2'', straight, packaged individually, sterile, disposable, box of 10

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More Product Details

Catalog Number

111638

Brand Name

Ambler Surgical

Version/Model Number

Atkinson retrobulbar anesthesia needle

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

f88ecbda-427e-468f-94b8-0d252e53f444

Public Version Date

January 12, 2021

Public Version Number

1

DI Record Publish Date

January 04, 2021

Additional Identifiers

Package DI Number

00190660198411

Quantity per Package

10

Contains DI Package

10190660198418

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