AccessGUDID - DEVICE: Omnifix™ (04046963441999)

GUDID

Device Identifier (DI) Information

Brand Name: Omnifix™
Version or Model: 4610522-02
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 4610522-02
Company Name: B. BRAUN MEDICAL INC.

Primary DI Number: 04046963441999
Issuing Agency: GS1
Commercial Distribution End Date: April 04, 2020
Device Count: 100
Labeler D-U-N-S® Number*: 002397347 *Terms of Use

Device Description: 5 mL LL 21 Ga. x 1 in.

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?
47017	General-purpose syringe, single-use	A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMI	Needle, hypodermic, single lumen
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
Total Volume: 5.0 Milliliter
Device Size Text, specify: Gauge (cannula) : 21

Device Record Status

Public Device Record Key: 04330fb2-04d9-45a5-b10d-9d7c370bac8c
Public Version Date: March 19, 2021
Public Version Number: 6
DI Record Publish Date: September 23, 2016