AccessGUDID - DEVICE: NUMELOCK II (07613327086614)

GUDID

Device Identifier (DI) Information

Brand Name: NUMELOCK II
Version or Model: S5SH18S
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: S5SH18S
Company Name: Stryker GmbH

Primary DI Number: 07613327086614
Issuing Agency: GS1
Commercial Distribution End Date: December 29, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 481999654 *Terms of Use

Device Description: Locking Screw

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:	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?
66947	Orthopaedic bone screw (non-sliding)	A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KTT	APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE 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
Length: 18.0 Millimeter
Device Size Text, specify: Diameter: 4.5 Millimeter

Device Record Status

Public Device Record Key: 9fb0cc25-c2fe-4805-8a01-b8abb9d3fa2f
Public Version Date: April 14, 2025
Public Version Number: 6
DI Record Publish Date: September 24, 2015