AccessGUDID - DEVICE: LLD 129 with rotation (08800018420706)

GUDID

Device Identifier (DI) Information

Brand Name: LLD 129 with rotation
Version or Model: LLD 129 with rotation
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: DRTECH Corporation

Primary DI Number: 08800018420706
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 689842626 *Terms of Use

Device Description: The LLD Bucky Stand is combined with the General Xray system, is generally applicable to Xray radiography in Long bone.

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):	Yes
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?
14473	X-ray film cassette holder	A device designed to position and hold the cassettes containing x-ray film during medical or dental imaging or radiation therapy procedures. It is used in conjunction with multiformat cameras and diagnostic imaging and radiation therapy modalities, e.g., nuclear medicine systems, ultrasound, computed tomography (CT), or magnetic resonance imaging (MRI).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IXY	Holder, Radiographic Cassette, Wall-Mounted

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: 1263124e-2a3c-4b6b-9ca6-579af73a54b9
Public Version Date: November 03, 2023
Public Version Number: 2
DI Record Publish Date: November 29, 2022