AccessGUDID - DEVICE: Panta® 2 (10381780505549)

GUDID

Device Identifier (DI) Information

Brand Name: Panta® 2
Version or Model: PAN-1010-0121
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PAN-1010-0121
Company Name: Ascension Orthopedics, Inc.

Primary DI Number: 10381780505549
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2026
Device Count: 1
Labeler D-U-N-S® Number*: 942377524 *Terms of Use

Device Description: Arthrodesis Nail System Handle, Nail Fixation Bolt

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?
35166	Bone nail driver	A hand-held manual surgical instrument designed to impart force on another instrument or directly on a bone fixation nail to insert the nail into tissue (i.e., to drive the nail into the intramedullary canal). It is typically made of high-grade stainless steel or titanium (Ti). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXH	ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

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
Special Storage Condition, Specify: Do Not Use if Package is Damaged

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: be8816e3-17f9-40cb-baa2-6e42fba850d6
Public Version Date: February 23, 2023
Public Version Number: 3
DI Record Publish Date: November 13, 2018