AccessGUDID - DEVICE: HedySeal Max Self-Sealing Sterilization Pouch (D903610HSM40)

GUDID

Device Identifier (DI) Information

Brand Name: HedySeal Max Self-Sealing Sterilization Pouch
Version or Model: 610HSM-40
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 610HSM-40
Company Name: AMD Medicom Inc

Primary DI Number: D903610HSM40
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 256880576 *Terms of Use

Device Description: HedySeal Max Pouches 3.5"x9" with Class 4 indicator detachable strips

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?
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
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

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
No Device Sizes

Device Record Status

Public Device Record Key: 06f401cb-c901-4dc4-a3d4-b55c7f504419
Public Version Date: July 16, 2020
Public Version Number: 3
DI Record Publish Date: January 17, 2019