AccessGUDID - DEVICE: Top Quality Manufacturing (TQ26BC226291)

GUDID

Device Identifier (DI) Information

Brand Name: Top Quality Manufacturing
Version or Model: BC2-2629
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TOP QUALITY MANUFACTURING, INC.

Primary DI Number: TQ26BC226291
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 113630649 *Terms of Use

Device Description: TQMPL - Phosphor Plate Barrier Envelopes - Size 0

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?
44824	Digital imaging cassette/phosphor plate	A device that includes both a digital imaging cassette and a phosphor plate (also known as screen) intended to receive radiation by a diagnostic x-ray system, to record a patient radiation pattern during a non-dental procedure. The device is then transferred, with the cassette shielding the plate from environmental light, to a computed radiography (CR) scanner for insertion to produce the digital image of the patient. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NRD	Unit, operative dental, accessories

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: 34d77744-5353-45f7-b6d1-a45c7b4478eb
Public Version Date: November 08, 2024
Public Version Number: 1
DI Record Publish Date: October 31, 2024