AccessGUDID - DEVICE: Femoral Head Remover, Corkscrew (00819251021876)

GUDID

Device Identifier (DI) Information

Brand Name: Femoral Head Remover, Corkscrew
Version or Model: 1339.00.000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TOTAL JOINT ORTHOPEDICS, INC.

Primary DI Number: 00819251021876
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078416717 *Terms of Use

Device Description: Femoral Head Remover, Corkscrew

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?
64297	Femoral head extractor	A surgical instrument designed to help remove the natural femoral head from within the acetabulum during a total hip replacement procedure. It is typically a one-piece instrument with a long slender shaft of various distal-end designs (e.g., screw, fork) intended to be inserted into the femoral neck/head after it has been excised from the femur. Rotational force is provided manually via a handle or by a powered drill/tool. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HWI	Corkscrew

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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: The Klassic HD Hip System should be stored in a clean, dry location at room temperature

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 66c06351-4888-4270-9b9d-fa03632367b7
Public Version Date: July 01, 2025
Public Version Number: 3
DI Record Publish Date: November 25, 2019