AccessGUDID - DEVICE: TL-HEX TRUELOK HEXAPOD SYSTEM (18053800895924)

GUDID

Device Identifier (DI) Information

Brand Name: TL-HEX TRUELOK HEXAPOD SYSTEM
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 50-20020
Company Name: ORTHOFIX SRL

Primary DI Number: 18053800895924
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 438793622 *Terms of Use

Device Description: TL-HEX KIT ID FRAME PEDIATRIC

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?
61577	Skin marking sticker	A hypoallergenic adhesive device (sticker) intended to be affixed to a patient’s skin (e.g., forehead) as a point of reference (marker), typically for use with external diagnostic imaging techniques. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
ILT	Adaptor, Recreational

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: No

Sterilization Method [?]
No Sterilization Methods Found

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: b9c736f2-d3e5-4243-94b8-ebb81b9e1dd3
Public Version Date: June 17, 2025
Public Version Number: 2
DI Record Publish Date: June 01, 2021

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: 0456719000
Email: info@orthofix.it

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