AccessGUDID - DEVICE: PRACTIshield Sheath Props (00723896009215)

GUDID

Device Identifier (DI) Information

Brand Name: PRACTIshield Sheath Props
Version or Model: 70-4970
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 70-4970
Company Name: PRACTICON, INC.

Primary DI Number: 00723896009215
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 119193803 *Terms of Use

Device Description: With new, high-visibility target graphics, PRACTIshield slips onto any needle sheath, creating an effective prop for easier one-handed resheathing. Helps to remind and reinforce a safe technique. Puncture-resistant die-cut cardboard. 100 single-use shields per pack.

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):	No
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?
36187	Needle recapping device, single-use	A device intended to hold a needle cap and allow a user to conveniently recap a needle, providing some user protection against needle sticks. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DZM	Needle, Dental

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9ad9879e-4566-47a5-bf0f-61df0e42f117
Public Version Date: August 20, 2018
Public Version Number: 1
DI Record Publish Date: July 18, 2018