AccessGUDID - DEVICE: CONTOURS PROXIMAL HUMERAL PLATE (PHP) & LSP TITANIUM HUMERAL PLATE (18032937169269)

GUDID

Device Identifier (DI) Information

Brand Name: CONTOURS PROXIMAL HUMERAL PLATE (PHP) & LSP TITANIUM HUMERAL PLATE
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TP1140
Company Name: ORTHOFIX SRL

Primary DI Number: 18032937169269
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 438793622 *Terms of Use

Device Description: MEASURER 2

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?
44796	Medical ruler, reusable	A small straight-edged strip intended to be used to measure the length of internal or external anatomy, devices or instruments in a clinical setting. It is marked in units of length (i.e., inches, millimetres and/or centimetres), and may be an independent rigid or bendable strip applied to measured surfaces or a strip incorporated into a form convenient for measuring specific devices (e.g., screws, endodontic files/rasps). It is not an implant sizer/prosthesis trial of a predetermined size, nor is it dedicated to wound measurements. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KTW	Appliance, Fixation, Nail/Blade/Plate Combination, Single Component

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K062920	000

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
No Device Sizes

Device Record Status

Public Device Record Key: a1a0cece-06a7-47c2-a051-254bb5d30614
Public Version Date: June 17, 2025
Public Version Number: 5
DI Record Publish Date: April 20, 2018