AccessGUDID - DEVICE: Dome Hole Plug (07613327037067)

GUDID

Device Identifier (DI) Information

Brand Name: Dome Hole Plug
Version or Model: 2060-0000-1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2060-0000-1
Company Name: Howmedica Osteonics Corp.

Primary DI Number: 07613327037067
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 058311945 *Terms of Use

Device Description: Acetabular Dome Hole Plug

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
56710	Acetabulum prosthesis hole plug	A sterile implantable device designed as a threaded or non-threaded plug intended to fill any hole of the shell component of a two-piece acetabulum prosthesis (shell and liner). It is made of metallic or polymer material, and is screwed or pushed into the hole after the implantation of the shell component.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
JDL	Prosthesis, hip, semi-constrained (metal cemented acetabular component)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
No Device Sizes

Device Record Status

Public Device Record Key: 409787bb-b1a6-44a9-9d04-5d0ca01c3a01
Public Version Date: July 26, 2022
Public Version Number: 5
DI Record Publish Date: September 24, 2015