AccessGUDID - DEVICE: Sternum clip Bar Elongation Pliers (04260029583267)

GUDID

Device Identifier (DI) Information

Brand Name: Sternum clip Bar Elongation Pliers
Version or Model: 010-01530
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 010-01530
Company Name: MedXpert GmbH

Primary DI Number: 04260029583267
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:	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?
58343	Rib/rib cage internal fixation/bracing system bending pliers	A hand-held manual surgical instrument designed to be used with a rib/rib cage internal fixation/bracing system for bending the rib grip or bracing bar implants to a specific shape, e.g., to modify the angulation of a rib clip. The instrument is typically made of high-grade steel and consists of two arms that form a handle proximally and extend distally through a pivot to form jaws that bend the metal rib grips or bracing bars allowing the surgeon to customize their shape. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MDM	Instrument, Manual, Surgical, General Use

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: 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: c2bb3266-8876-404a-a46a-686760558c82
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: May 11, 2017