AccessGUDID - DEVICE: Rospital Productos Medicos (00812460026878)

GUDID

Device Identifier (DI) Information

Brand Name: Rospital Productos Medicos
Version or Model: TB125
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TB125
Company Name: ATLAS MEDICAL PRODUCTS LLC

Primary DI Number: 00812460026878
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 013112308 *Terms of Use

Device Description: 1ML TUBERCULIN SYRINGE WITH DETACHABLE NEEDLE LUER LOCK 25G X 5/8 IN, EACH

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?
63096	Tuberculin/allergy syringe/needle, basic	A sterile device consisting of a calibrated barrel (cylinder) with plunger, intended to be used to administer a precise, low-dosage injection of tuberculin and/or sensitivity test allergen to a patient subcutaneously; a non-retractable needle is included, either attached or detached (usually capped for user protection). The syringe is typically made of plastic and silicone materials and will have plunger anti-sticking properties allowing smooth plunger movement. It can be used by healthcare personnel or patients. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMF	Syringe, Piston
FMI	Needle, Hypodermic, Single Lumen

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K060211	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
Device Size Text, specify: 1ML TUBERCULIN SYRINGE WITH DETACHABLE NEEDLE LUER LOCK 25G X 5/8 IN, EACH

Device Record Status

Public Device Record Key: bd057c01-2cc0-4521-b39e-4eeb44cea196
Public Version Date: November 06, 2023
Public Version Number: 3
DI Record Publish Date: July 06, 2020