AccessGUDID - DEVICE: FEMORAL HOOK SUPPORT, SSXT (00842430113956)

GUDID

Device Identifier (DI) Information

Brand Name: FEMORAL HOOK SUPPORT, SSXT
Version or Model: 6870-90
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6870-90
Company Name: MIZUHO ORTHOPEDIC SYSTEMS, INC.

Primary DI Number: 00842430113956
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 084527241 *Terms of Use

Device Description: No description.

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):	No
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?
62665	Femur lifter, manual	A manually-operated, multi-jointed, mechanical device intended to support and elevate a patient¿s femur for optimal positioning during hip replacement surgery. It is designed to be fixed to an operating table and includes a vertical lifting post, a handcrank for height adjustment, mounting clamps/adaptors, and leg support components. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JEA	Table, Surgical With Orthopedic Accessories, Ac-Powered

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
No Device Sizes

Device Record Status

Public Device Record Key: b5a3eac7-486a-4a92-b2c3-d22d73870a77
Public Version Date: October 21, 2020
Public Version Number: 1
DI Record Publish Date: October 13, 2020