AccessGUDID - DEVICE: CervAlign Anterior Cervical Plate System (00846468088064)

GUDID

Device Identifier (DI) Information

Brand Name: CervAlign Anterior Cervical Plate System
Version or Model: 66-BENDER
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 66-BENDER
Company Name: Pioneer Surgical Technology, Inc.

Primary DI Number: 00846468088064
Issuing Agency: GS1
Commercial Distribution End Date: November 18, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 793384496 *Terms of Use

Device Description: Plate Bender

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:	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?
44795	Manual orthopaedic bender, reusable	A manually-operated surgical instrument designed to bend orthopaedic devices, typically those for implantation (e.g., orthopaedic rods, bone fixation plates), to an appropriate anatomical shape. The bending process is typically performed within the operating room (OR), inside or outside of the operative sterile field. The device may be hand held or table mounted. 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: 9eb9f41b-4f54-4500-9976-d148bd6fbebd
Public Version Date: August 02, 2024
Public Version Number: 4
DI Record Publish Date: February 20, 2019