AccessGUDID - DEVICE: Rando® (00812266030987)

GUDID

Device Identifier (DI) Information

Brand Name: Rando®
Version or Model: XA245R
Commercial Distribution Status: In Commercial Distribution
Catalog Number: XA245R
Company Name: Providus Holdings, Inc.

Primary DI Number: 00812266030987
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 104162493 *Terms of Use

Device Description: Knee 90° flexion, right

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?
40615	General-purpose diagnostic x-ray phantom, anthropomorphic	A device that consists of preserved human or animal tissue, or a two or three-dimensional (3-D) tissue-equivalent model designed to mimic the functional, physical, or a combination of these characteristics of a normal or diseased human organ or organ systems. It is a quality assurance (QA) device intended to permit both subjective and quantitative evaluation of the overall function of both conventional and digital general-purpose x-ray systems and associated image acquisition, display and analysis computer programs. The design can incorporate fluid pumps and moveable components. This GMDN code includes biopsy and other kinds of interventional procedure training phantoms.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IXG	Phantom, Anthropomorphic, Radiographic

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: c0eb8be4-d925-4eaa-9547-d2c5e65c65b2
Public Version Date: July 19, 2024
Public Version Number: 1
DI Record Publish Date: July 11, 2024

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: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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