AccessGUDID - DEVICE: Reconstruction Plate Bending Pliers (00853190008109)

GUDID

Device Identifier (DI) Information

Brand Name: Reconstruction Plate Bending Pliers
Version or Model: 215.010.35
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: JACE MEDICAL, LLC

Primary DI Number: 00853190008109
Issuing Agency: GS1
Commercial Distribution End Date: November 26, 2055
Device Count: 1
Labeler D-U-N-S® Number*: 063554875 *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":	No
For Single-Use:	No
Prescription Use (Rx):	No
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?
47637	Bone fixation plate pliers	A manual surgical instrument designed to bend and cut light-bone fixation plates (e.g., 1 to 2 mm in thickness), such as those used in craniomaxillofacial (CMF) or finger surgery. The instrument is typically made of high-grade steel and consists of two arms/rods that form a handle proximally and extend distally through a pivot to form jaws that bend and cut the metal plates allowing the surgeon to customize their size and shape. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HXP	Instrument, Bending Or Contouring

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: 44a02f86-9dbe-4604-acde-cf2504ffe8f0
Public Version Date: May 30, 2025
Public Version Number: 3
DI Record Publish Date: September 28, 2018