AccessGUDID - DEVICE: Health-Tec Sterilization Wrap (D773590100121)

GUDID

Device Identifier (DI) Information

Brand Name: Health-Tec Sterilization Wrap
Version or Model: 590-10012
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 590-10012
Company Name: Dental Health Products Inc

Primary DI Number: D773590100121
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 623191194 *Terms of Use

Device Description: Health-Tec Sterilization Wrap 24" X 24"

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?
13735	Sterilization packaging, single-use	A device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRG	Wrap, Sterilization

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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
Area/Surface Area: 24 Square inch

Device Record Status

Public Device Record Key: c4fb1c3d-371b-4d49-9c34-9ad9709db514
Public Version Date: November 08, 2019
Public Version Number: 3
DI Record Publish Date: January 24, 2017