AccessGUDID - DEVICE: Signature ONE Software Package (00889024647039)

GUDID

Device Identifier (DI) Information

Brand Name: Signature ONE Software Package
Version or Model: 302.4018
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 302.4018
Company Name: Orthosoft Inc

Primary DI Number: 00889024647039
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 205670032 *Terms of Use

Device Description: v. 1.1

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?
57812	Radiology DICOM image processing application software	A software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/disc burning) and/or image quality manipulation and quantification (e.g., non-interpretive graphical overlays).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QHE	Shoulder Arthroplasty Implantation System
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
PHX	Shoulder Prosthesis, Reverse Configuration

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K190595	000
K192074	000
K200615	000

Device Exempt from Premarket Submission: No 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: c6c7053e-4b62-4236-a9bd-571854f88be2
Public Version Date: December 04, 2023
Public Version Number: 2
DI Record Publish Date: July 05, 2022

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

Customer Contact

[?]

No Customer Contact currently defined

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