AccessGUDID - DEVICE: Inserter Coupling Screw 9mm & 10mm (08437019739577)

GUDID

Device Identifier (DI) Information

Brand Name: Inserter Coupling Screw 9mm & 10mm
Version or Model: 21
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ABANZA TECNOMED SL.

Primary DI Number: 08437019739577
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 465714287 *Terms of Use

Device Description: Instrument used to couple the cap of the WasherCap™ Fixation System to the inserter, threading it into the inserter until the “device-inserter” assembly is fully engaged.

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?
47831	Orthopaedic implantation sleeve, reusable	A hand-held tubular surgical device designed to be used during an orthopaedic implantation procedure to hold/grip an implant (e.g., an orthopaedic bone screw), facilitate the acceptance of an orthopaedic instrument (e.g., a screwdriver or a smaller diameter sleeve) through it, stabilize an instrument/implant coupling, and/or protect the surgeon's gloved hand or patient tissue. It is not primarily intended to place, angle, and guide a rotating surgical drill. It is typically made of high-grade stainless steel and/or synthetic materials and is available in various sizes and lengths. 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8d7cb8ce-03f1-4e7d-8e98-9411fc2d5e2f
Public Version Date: June 09, 2023
Public Version Number: 1
DI Record Publish Date: June 01, 2023