AccessGUDID - DEVICE: Ascension® PyroSphere (10381780114604)

GUDID

Device Identifier (DI) Information

Brand Name: Ascension® PyroSphere
Version or Model: PCS43030WW
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PCS-430-30-WW
Company Name: Ascension Orthopedics, Inc.

Primary DI Number: 10381780114604
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2026
Device Count: 1
Labeler D-U-N-S® Number*: 942377524 *Terms of Use

Device Description: Single-use, spherical, interpositional prosthesis for the basal thumb joint.

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):	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?
40126	Metacarpal prosthesis	A sterile implantable device designed to replace the proximal end (base) of the first metacarpal of the thumb carpometacarpal (CMC) joint (articulation with the trapezium) typically to treat thumb instability/motion disabilities caused by arthritis or fracture. It is typically a one-piece device, made of one or several materials (e.g., carbon, graphite, metal); implantation may be performed with our without bone cement.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KYI	PROSTHESIS, WRIST, CARPAL TRAPEZIUM

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K042690	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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
Device Size Text, specify: Size 30

Device Record Status

Public Device Record Key: 0b98a0ec-8119-4da0-ba85-d568cebe078d
Public Version Date: February 23, 2023
Public Version Number: 6
DI Record Publish Date: October 09, 2017