AccessGUDID - DEVICE: Medical Action Industries (20809160005467)

GUDID

Device Identifier (DI) Information

Brand Name: Medical Action Industries
Version or Model: 56237
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDICAL ACTION INDUSTRIES INC.

Primary DI Number: 20809160005467
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 960
Labeler D-U-N-S® Number*: 092364462 *Terms of Use

Device Description: Inst: Thumb Plastic 5 in 960/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:	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?
47570	Utility forceps, single-use	A sterile, hand-held, manual surgical instrument designed for general-purpose grasping/picking up of other devices/objects typically with the intention of maintaining a sterile condition or avoiding direct hand contact because of unhygienic/unfavourable conditions. It typically has a scissors-like design with ring handles and is made of high-grade stainless steel or plastic material. It is available in various sizes and the working end will typically have grasping blades that are elongated or shaped as large oval or triangular rings. The blades are usually serrated to enhance grip on the objects being picked up. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KDC	INSTRUMENT, SURGICAL, 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: c674e8c7-c846-4429-98f3-5ab8cc15eb9e
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 20, 2016