AccessGUDID - DEVICE: GARG (20653405052859)

GUDID

Device Identifier (DI) Information

Brand Name: GARG
Version or Model: THR-1720
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: THR-1720
Company Name: Conmed Corporation

Primary DI Number: 20653405052859
Issuing Agency: GS1
Commercial Distribution End Date: August 09, 2021
Device Count: 5
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: GARG THORACENTESIS NEEDLE

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):	Yes
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?
35886	Body aspiration needle, single-use	A sterile, sharp bevel-edged, hollow tubular metal instrument designed to remove fluid from a body cavity or to obtain a biopsy specimen from a patient through aspiration; it is not dedicated to a particular part of the anatomy. The device is typically longer than a hypodermic needle and usually has a wider hub. It is not intended for administration of pharmaceuticals. 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 [?]
K894326	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 2.3 Millimeter
Length: 8 Centimeter

Device Record Status

Public Device Record Key: 84a97bd8-55f3-4567-8774-3678e136da96
Public Version Date: August 10, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2016