AccessGUDID - DEVICE: Acetabular reamer ø53mm (07630055300607)

GUDID

Device Identifier (DI) Information

Brand Name: Acetabular reamer ø53mm
Version or Model: 9055.IN.053 00
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9055.IN.053 00
Company Name: Incipio Devices SA

Primary DI Number: 07630055300607
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 485098284 *Terms of Use

Device Description: Acetabular reamer for hip arthroplasty

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?
32848	Acetabular orthopaedic reamer	An orthopaedic surgical instrument designed to cut and resurface with precision the acetabulum for the acceptance of the acetabular component of a hip joint prosthesis. The device is designed with a hemispherical shell with an abrasive outer surface as the cutting head that is attached to a shaft for manual or powered rotation. It is typically made of a high-grade stainless steel alloy and is available in various sizes. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HTO	Reamer

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 53 Millimeter

Device Record Status

Public Device Record Key: 0456f1ee-d01d-4af6-b284-0deebbffd78b
Public Version Date: February 24, 2020
Public Version Number: 1
DI Record Publish Date: February 14, 2020