AccessGUDID - DEVICE: Medical Action Industries (10809160016657)

GUDID

Device Identifier (DI) Information

Brand Name: Medical Action Industries
Version or Model: 71837B
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MEDICAL ACTION INDUSTRIES INC.

Primary DI Number: 10809160016657
Issuing Agency: GS1
Commercial Distribution End Date: November 12, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 092364462 *Terms of Use

Device Description: No description.

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?
13894	Suture removal kit	A collection of various sterile instruments, dressings, and pharmaceuticals designed to remove sutures from a patient. It typically includes a disinfectant, scissors, forceps, gauze and bandages. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MCZ	Suture removal kit

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 51473397-0a0c-433d-bc65-de9b67d5cc60
Public Version Date: November 15, 2021
Public Version Number: 3
DI Record Publish Date: August 20, 2016