AccessGUDID - DEVICE: PANTA (10381780050797)

GUDID

Device Identifier (DI) Information

Brand Name: PANTA
Version or Model: 501100ND
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 501100ND
Company Name: NEWDEAL

Primary DI Number: 10381780050797
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: Bony fixation of Panta nail is achieved using two tibial screws, two calcaneal screws and one talar screw. Holes in the nail allow for proximal and distal locking, using locking cortical screws (fully threaded or partially threaded) 5 mm diameter, from 20 to 110 mm length.

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?
46646	Orthopaedic bone screw, non-bioabsorbable, sterile	A small, sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). There are a number of kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression across bone fragments.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HSB	ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K050882	000
K091788	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store in dry place

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 5.0mm diam. x 100mm length

Device Record Status

Public Device Record Key: dd9f9704-084e-4f3c-880a-97a8c19e8224
Public Version Date: February 19, 2024
Public Version Number: 5
DI Record Publish Date: October 09, 2017