AccessGUDID - DEVICE: Blunt Fill Needles 18G x 1 ½” (00853620005371)

GUDID

Device Identifier (DI) Information

Brand Name: Blunt Fill Needles 18G x 1 ½”
Version or Model: 038089689500
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Merit Pharmaceutical

Primary DI Number: 00853620005371
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 093370369 *Terms of Use

Device Description: No description.

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":	Yes
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?
35210	Exploratory blunt needle, single-use	A sterile, slender, hand-held manual instrument designed with a dull curved tip intended to prevent damage to sensitive and delicate tissues while it is being used to explore within the body. 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: c1458722-1e40-47b4-9313-32f8a50883bf
Public Version Date: February 01, 2019
Public Version Number: 1
DI Record Publish Date: January 01, 2019