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Panta®

FDA UDI

Class I (US FDA UDI)

by Newdeal Sas

Identity

Trade Name
PANTA® FDA UDI
Generic Name
Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
Device Name
The "T" handle extractor is used to extract Panta® Nails and belongs to the Panta® Nail Removal Kit. FDA UDI
Model / Reference
519210ND FDA UDI
Description
The "T" handle extractor is used to extract Panta® Nails and belongs to the Panta® Nail Removal Kit. FDA UDI

Identifiers

Primary DI / UDI-DI
10381780046028 FDA UDI
FDA Product Code
HWB FDA UDI
GMDN Term
Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic inorganic implant inserter/extractor, reusable

Panta® by Newdeal Sas — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic inorganic implant inserter/extractor, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Newdeal Sas

Sources (1)

  • FDA UDI f54365a1-cb64-44f8-8794-7d53965f4fcf 35 fields · synced May 30, 2026