AccessGUDID - DEVICE: Medical Action Industries (10809160021255)

GUDID

Device Identifier (DI) Information

Brand Name: Medical Action Industries
Version or Model: 80075
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDICAL ACTION INDUSTRIES INC.

Primary DI Number: 10809160021255
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 092364462 *Terms of Use

Device Description: Kit: Nail Care 50/Cs

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):	No
Over the Counter (OTC):	Yes
Kit:	Yes
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?
58940	Podiatry kit, single-use	A collection of devices intended for treatment of cutaneous foot disorders such as hardened skin, corns, and ingrown/ingrowing toenails. It typically consists of two or more of the following items: nail cutters, nail file, dermal curette, scalpel handle and blades, probe, gauze applicators, and/or dressings (e.g., coverings, protection/treatment solutions); it may be used in the home and healthcare facility. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KDD	Kit, surgical instrument, disposable

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: store at room temperature
Special Storage Condition, Specify:

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6a0d65ce-71a6-4255-994a-37bb7c1a4503
Public Version Date: November 06, 2020
Public Version Number: 3
DI Record Publish Date: August 20, 2016