AccessGUDID - DEVICE: ORTHOFIX (18059015371017)

GUDID

Device Identifier (DI) Information

Brand Name: ORTHOFIX
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 99-60003629
Company Name: ORTHOFIX SRL

Primary DI Number: 18059015371017
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 438793622 *Terms of Use

Device Description: FITBONE TRANSPORT LENGTHENING TRIAL NAIL TLN 1140-F-40-310 STERILE

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
66957	Bone nail trial, single-use	A copy of a final orthopaedic bone nail designed to be introduced into the bone (e.g., proximal and/or distal end of the intramedullary canal of a long bone) to function as a reference for the subsequent introduction of the final bone nail, and typically also guide wire and/or bone screws. It is typically used in conjunction with appropriate holders/positioning devices (not included). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HSB	Rod, Fixation, Intramedullary And Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K232169	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
Length: 310 Millimeter
Outer Diameter: 11 Millimeter

Device Record Status

Public Device Record Key: f7666301-c0f0-4832-a324-cedc5634e924
Public Version Date: June 17, 2025
Public Version Number: 3
DI Record Publish Date: April 23, 2024

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: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +0390456719000
Email: info@orthofix.it

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