AccessGUDID - DEVICE: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT (03701037313480)

GUDID

Device Identifier (DI) Information

Brand Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Version or Model: 904-1015
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 904-1015
Company Name: FX SOLUTIONS

Primary DI Number: 03701037313480
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 263076196 *Terms of Use

Device Description: STABILITY TRIAL CUP Ø40 + 15 STANDARD TRIAL HUMERAL CUP 135/145° Ø32 +15

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?
44054	Orthopaedic surgical procedure kit, non-medicated, reusable	A collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXH	Orthopedic Manual Surgical Instrument

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
Special Storage Condition, Specify: Store away from light and sunlight Store away from moisture

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5193cd12-6974-43d3-a094-c22fa51bdb71
Public Version Date: October 08, 2021
Public Version Number: 2
DI Record Publish Date: May 20, 2020