AccessGUDID - DEVICE: Smart SPACE SHOULDER (08033390237017)

GUDID

Device Identifier (DI) Information

Brand Name: Smart SPACE SHOULDER
Version or Model: 0023.R3.N33.A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0023.R3.N33.A
Company Name: LIMACORPORATE SPA

Primary DI Number: 08033390237017
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 432066322 *Terms of Use

Device Description: Smart SPACE SHOULDER - Humerus Anatomical Model-RIGHT3-NOT STER

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?
62215	Custom-made organ/bone anatomy model	A model of an organ (e.g., heart, kidney, lung) or bone of a specific patient intended to be used to assist anatomical visualization and surgical treatment planning. It is created using additive (three-dimensional [3-D] printing) processes based on patient medical images. It is typically made of a synthetic polymer, marked with a unique identifier.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K222405	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: b7b44694-bb51-451f-8f26-07d6f3191296
Public Version Date: August 20, 2024
Public Version Number: 2
DI Record Publish Date: February 18, 2023