AccessGUDID - DEVICE: Doctors Choice (G018S325625SN10)

GUDID

Device Identifier (DI) Information

Brand Name: Doctors Choice
Version or Model: S325625SN1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Supply Line International Medical, LLC

Primary DI Number: G018S325625SN10
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079241502 *Terms of Use

Device Description: Syringe 3 ml LL, 25G x 5/8"

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?
36280	Medication cartridge syringe, safety-needle	A sterile device consisting of a breech-loading metal barrel with plunger into which a hermetically-sealed glass cartridge containing medication is intended to fit. The device uses an attached protective recessed or shielded needle for hypodermic drug delivery. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMF	Syringe, Piston

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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: 52e973ea-0866-43b8-9400-841a90f617ba
Public Version Date: January 19, 2021
Public Version Number: 1
DI Record Publish Date: January 11, 2021