AccessGUDID - DEVICE: UR-4MD (04907034602049)

GUDID

Device Identifier (DI) Information

Brand Name: UR-4MD
Version or Model: 1921062000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Dongguan Teac Electronics Co., Ltd.

Primary DI Number: 04907034602049
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 544883143 *Terms of Use

Device Description: UR-4MD VIDEO REC

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:	No
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?
63260	Medical video image recorder	An electrically-powered device designed to be used in conjunction with video endoscopes, radiological equipment, and/or surgical video imaging devices (e.g., surgical microscope, camera) to digitally record video images for subsequent playback; it is not intended for distribution/routing of image data within a network (i.e., not a medical image management system). It is typically a portable device that may incorporate a small screen intended only to reference image capture.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LMB	Device, Digital Image Storage, Radiological

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: efd1db08-374d-4f79-a5fe-c4a90fb99e18
Public Version Date: July 06, 2023
Public Version Number: 3
DI Record Publish Date: September 24, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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