AccessGUDID - DEVICE: PANTA® (10381780045540)

GUDID

Device Identifier (DI) Information

Brand Name: PANTA®
Version or Model: 519004ND
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 519004ND
Company Name: NEWDEAL

Primary DI Number: 10381780045540
Issuing Agency: GS1
Commercial Distribution End Date: April 19, 2027
Device Count: 1
Labeler D-U-N-S® Number*: 536935331 *Terms of Use

Device Description: The drill of diameter 4.3 mm and of total length 210 mm is used to pre-drill before the insertion of the tibial screws and the optional talar screw.

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:	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?
43390	Fluted surgical drill bit, single-use	A shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is mounted into a surgical power tool or a surgical hand drill/brace. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HTW	BIT, DRILL

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
Device Size Text, specify: 4.3mm diam. x 177mm working length

Device Record Status

Public Device Record Key: ebab50e5-aa2a-466b-b658-66ad03a3e447
Public Version Date: February 06, 2023
Public Version Number: 5
DI Record Publish Date: May 26, 2017