AccessGUDID - DEVICE: SMR Shoulder (08033390118323)

GUDID

Device Identifier (DI) Information

Brand Name: SMR Shoulder
Version or Model: Bone Graft Instrument Set
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9013.75.471
Company Name: LIMACORPORATE SPA

Primary DI Number: 08033390118323
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 432066322 *Terms of Use

Device Description: Bone Graft Instrument Set - 15° Graft Shaper

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?
45109	Orthopaedic reamer guide	An orthopaedic surgical device that functions as a guide for an orthopaedic reamer. The guide, commonly called a spigot, is inserted into a predetermined site where bone is to be resected for the acceptance of a prosthetic implant, typically at or within a joint (e.g., the condyle head of the knee, the olecranon of the ulna) or for the reaming of the intramedullary canal for acceptance of an intramedullary nail. The device allows the controlled cutting action of the reamer which is steered down its length. It is typically made of a high-grade stainless steel alloy; it comes in varying sizes. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
PHX	Shoulder Prosthesis, Reverse Configuration

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K161120	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
Device Size Text, specify: 15°

Device Record Status

Public Device Record Key: 8ac07b72-600a-4ede-a14f-3252fa53d078
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: February 25, 2017