AccessGUDID - DEVICE: Titanium 3D rib clip, 9 segments,XL (04260029583588)

GUDID

Device Identifier (DI) Information

Brand Name: Titanium 3D rib clip, 9 segments,XL
Version or Model: 014-02009
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 014-02009
Company Name: MedXpert GmbH

Primary DI Number: 04260029583588
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 331019344 *Terms of Use

Device Description: No description.

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":	Yes
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?
58339	Rib/rib cage internal fixation/bracing system fixation grip/anchor	A non-sterile implantable device designed to be clasped around a rib and to connect bracing bars for bridging congenital or postsurgical deficits in the rib cage. It typically consists of a narrow plate with pairs of fenestrated gripping arms and a straight or angled holding arm for attachment (anchoring) of a bracing bar; it is made of metal [e.g., titanium (Ti)]. It can be surgically removed when required or remain in situ. This device must be sterilized prior to use.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HRS	Plate, Fixation, Bone

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
No Device Sizes

Device Record Status

Public Device Record Key: e292a047-4a15-4d33-aec9-8c5ecc107ee1
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: January 05, 2017