AccessGUDID - DEVICE: Ceros (00850041572765)

GUDID

Device Identifier (DI) Information

Brand Name: Ceros
Version or Model: RM-SN0112805TB
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RM-SN0112805TB
Company Name: Rhino Medical Supply Inc

Primary DI Number: 00850041572765
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117524559 *Terms of Use

Device Description: Ceros Tuberculin Needle & Syringe, 1 mL, 28 G x 1/2", Gray Polypropylene Hub, Latex Free, DEHP Free, PVC Free

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?
63095	General-purpose syringe/needle	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 non-retractable needle is included, either attached or detached (usually capped for user protection). It is intended for various medical applications and is not dedicated to medication administration. The syringe 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
FMF	Syringe, Piston
FMI	Needle, Hypodermic, Single Lumen
MEG	Syringe, Antistick

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K192551	000

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: 1 Milliliter
Needle Gauge: 28 Gauge
Length: .5 Inch

Device Record Status

Public Device Record Key: 48932370-481b-41a0-acbb-c7e2fef5e201
Public Version Date: March 27, 2024
Public Version Number: 1
DI Record Publish Date: March 19, 2024