AccessGUDID - DEVICE: Bone Screws (18033509850264)

GUDID

Device Identifier (DI) Information

Brand Name: Bone Screws
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 99-10138
Company Name: ORTHOFIX SRL

Primary DI Number: 18033509850264
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 438793622 *Terms of Use

Device Description: CORTICAL SCREW 120/30 MM STERILE SHAFT D 6MM THREAD D 4.5-3.5MM

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?
32845	Surgical depth gauge, reusable	A surgical instrument designed to measure the depth of a recess, usually to measure the depth of holes being drilled in bone so that the surgeon can determine the length of the bone screw to be used. It may take two forms: 1) a device with a moveable (sliding) centrepiece (a prong), the tip of which is inserted into the recess to read from a scale; 2) a circular disc with a central hole which is clipped to a drill bit so that the device slides up as the drill bit is advanced. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JDW	Pin, Fixation, Threaded

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K955848	000

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
Device Size Text, specify: THREAD MINOR DIAMETER 3,5 MM
Device Size Text, specify: THREAD MAJOR DIAMETER 4,5 MM
Outer Diameter: 6 Millimeter
Device Size Text, specify: THREAD LENGHT 30 MM
Length: 120 Millimeter

Device Record Status

Public Device Record Key: a82e1d0a-8e7e-4494-ad69-6e182b24c9db
Public Version Date: June 17, 2025
Public Version Number: 5
DI Record Publish Date: September 01, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: Yes
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +039456719000
Email: info@orthofix.it

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES