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Panta® 2

FDA UDI

Class I (US FDA UDI)

by Ascension Orthopedics, Inc.

Identity

Trade Name
Panta® 2 FDA UDI
Generic Name
Fluted surgical drill bit, single-use FDA UDI
Device Name
Arthrodesis Nail System Long Calcaneal Drill, ø4.1mm FDA UDI
Model / Reference
PAN-1010-0003 FDA UDI
Description
Arthrodesis Nail System Long Calcaneal Drill, ø4.1mm FDA UDI

Identifiers

Catalog Number
PAN-1010-0003 FDA UDI
Primary DI / UDI-DI
10381780505792 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Fluted surgical drill bit, single-use 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

Yes

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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Fluted surgical drill bit, single-use

Panta® 2 by Ascension Orthopedics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Fluted surgical drill bit, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ascension Orthopedics, Inc.

Sources (1)

  • FDA UDI 9b6f718d-06c7-47fa-b65a-313ceb86b69c 38 fields · synced Jun 8, 2026