AccessGUDID - DEVICE: Duraholder (10687225799031)

GUDID

Device Identifier (DI) Information

Brand Name: Duraholder
Version or Model: Y5647878
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PDC-DURA102/100
Company Name: PRECISION DYNAMICS CORPORATION

Primary DI Number: 10687225799031
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 008486367 *Terms of Use

Device Description: Duraholder, 12.5X17.25 inch 6 Pockets, 2 Rows with Slits; Instrument Holder, 100 Case

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):	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?
31072	Personal device holder, single-use	A portable, flexible device designed to hold a portable medical device (e.g., long-term recorder, portable oxygen equipment, urine collection bag, tracheostoma protector) during ambulation or sleep; it is neither designed to hold an invasive tube/catheter to the skin surface (i.e., not a catheter/tube holder), nor to house and protect a device from damage (i.e., not a rigid case/housing). It is typically designed as a bag, pouch, strap, belt, or clothing. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MDM	Instrument, Manual, Surgical, General Use

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: 03068f80-8c16-45df-bdd3-9410a5c6aaaf
Public Version Date: January 24, 2024
Public Version Number: 1
DI Record Publish Date: January 16, 2024