AccessGUDID - DEVICE: Implant cutting pliers with exchangeable jaw inserts, narrow, 22 cm (04260029580648)

GUDID

Device Identifier (DI) Information

Brand Name: Implant cutting pliers with exchangeable jaw inserts, narrow, 22 cm
Version or Model: 010-00011
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 010-00011
Company Name: MedXpert GmbH

Primary DI Number: 04260029580648
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?
58342	Rib/rib cage internal fixation/bracing system cutting pliers	A hand-held manual surgical instrument designed to be used with a rib/rib cage internal fixation/bracing system for cutting the rib grip or bracing bar implants to a specific size. The instrument is typically made of high-grade steel and consists of two pivoted or multi-pivoted handles that form a handle proximally and when squeezed together, close the jaws distally to bite (cut) through the metal implants. It typically will have replaceable blades. 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: 096bbcb5-d523-423f-b9d8-db6b5f257667
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: January 05, 2017