AccessGUDID - DEVICE: Aspirating Needle (B21232311)

GUDID

Device Identifier (DI) Information

Brand Name: Aspirating Needle
Version or Model: 32-31
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 32-31
Company Name: INTERNATIONAL MEDICAL INDUSTRIES INC.

Primary DI Number: B21232311
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 053469565 *Terms of Use

Device Description: 16 Gauge x 5" Aspirating Needle, W/ Blunt Cannula. Sterile & Non-Pyrogenic, Individually Blister Packed, Box of 100

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
16627	Medication transfer needle, non-filtering/non-vented	A slender, rigid, sharp or blunt metal tube intended to be attached to a syringe and typically used in the pharmacy to aspirate and transfer fluid medication from a vial/ampule to another container for medication preparation or other purposes. It consists of a short needle sufficient to penetrate the vial stopper and extract all the medication. It is typically of 20 gauge to provide a high-flow rate with minimum coring. It does not include a filter or a back-pressure venting feature. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GAA	Needle, Aspiration And Injection, Disposable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 238d0109-77d4-4b72-90ad-84f6d1b3b084
Public Version Date: August 09, 2019
Public Version Number: 3
DI Record Publish Date: September 23, 2016