AccessGUDID - DEVICE: ST-9 (B682100012)

GUDID

Device Identifier (DI) Information

Brand Name: ST-9
Version or Model: ST-9 1000-12
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: ST-9 1000-12
Company Name: MEDSCIENCE RESEARCH GROUP, INC.

Primary DI Number: B682100012
Issuing Agency: HIBCC
Commercial Distribution End Date: November 30, 2021
Device Count: 12
Labeler D-U-N-S® Number*: 013114656 *Terms of Use

Device Description: Asymmetric Multiple Skin Testing Device for Percutaneous Skin Testing, 12 applicators individually package and sold as a unit of 12 applicators.

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":	No
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?
45539	Allergy testing lancet	A sterile device with a sharp triangular cutting edge at the distal end designed to manually breach the epidermis to facilitate the diagnosis of allergic reactions in skin allergy testing performed by an allergist or other healthcare professional. It is held between the fingertips and pressed transiently, but firmly (not jabbed), at right angles through a drop of an allergen extract into the flexor side of the forearm of a suspected allergic individual. The tip penetrates only the most superficial layers of the skin allowing a small volume of the allergen extract to enter the skin and diffuse into the skin layers below. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LDH	System, Delivery, Allergen And Vaccine

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K172062	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
Handling Environment Temperature: between -40 and 140 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 56522603-959b-4008-9ff9-483730b13b86
Public Version Date: January 21, 2025
Public Version Number: 3
DI Record Publish Date: November 30, 2018