AccessGUDID - DEVICE: Large Bending Pliers with Springs (00810028391352)

GUDID

Device Identifier (DI) Information

Brand Name: Large Bending Pliers with Springs
Version or Model: 330-00-010
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Trilliant Surgical, LLC

Primary DI Number: 00810028391352
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 828829072 *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):	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?
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
HXW	Bender

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: 118bc580-4de8-4d38-9c8b-abf3e9586093
Public Version Date: April 06, 2022
Public Version Number: 2
DI Record Publish Date: October 01, 2019