AccessGUDID - DEVICE: PANTA® (10381780045106)

GUDID

Device Identifier (DI) Information

Brand Name: PANTA®
Version or Model: 519016ND
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NEWDEAL

Primary DI Number: 10381780045106
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 classical reamer of diameter 12.5 mm and of total length 300 mm is used to ream the intramedullary canal to prepare the nail insertion.

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?
61807	Bone-resection orthopaedic reamer, single-use	An orthopaedic surgical instrument intended to resect bone (cut out part of the bone), and in some cases hypertrophic tissue [e.g., ligamentum flavum], to: 1) accept a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna); and/or 2) relieve pressure at or facilitate access to a joint. Commonly called a mill or a reamer, it is typically designed as a stainless steel cylindrical body with an end/circumferential cutting edge and is attached to a shaft for manual or powered rotation. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HTO	REAMER

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: 12.5mm diam. x 40mm reaming part length

Device Record Status

Public Device Record Key: 14e8d1c1-f0c6-478c-8fc7-f939f7699cba
Public Version Date: October 04, 2023
Public Version Number: 6
DI Record Publish Date: May 26, 2017