AccessGUDID - DEVICE: CENTRONAIL TITANIUM HUMERAL NAILING SYSTEM (18032937168842)

GUDID

Device Identifier (DI) Information

Brand Name: CENTRONAIL TITANIUM HUMERAL NAILING SYSTEM
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 173058
Company Name: ORTHOFIX SRL

Primary DI Number: 18032937168842
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 438793622 *Terms of Use

Device Description: SPACER NAIL 7 MM

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?
47913	Bone-nailing spacer	A cylindrical rod-like device used as a precision reference to provide the correct spatial distance between an an intramedullary bone nail (femoral, humeral, tibial) to which it is interfaced, and an aiming arm, joining the two in a relative position. This procedure is performed to set-up the aiming arm prior to surgery; the set-up is dismantled and then reconnected after implantation of the nail with this device (the spacer) which is percutaneously introduced into a selected hole in the bone nail. It is typically made of high-grade stainless steel or synthetic materials. Several reference spacers may be used for this procedure. This is a reusable 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 [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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
Width: 25 Millimeter

Device Record Status

Public Device Record Key: 9877b05f-1142-4aac-8915-6b2041ff734f
Public Version Date: June 17, 2025
Public Version Number: 2
DI Record Publish Date: April 28, 2018

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

Customer Contact

[?]

Phone: +0390456719000
Email: info@orthofix.it

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