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Omnia Medical PSiFDNA

FDA UDI

Class II (US FDA UDI)

by Omnia Medical

Identity

Trade Name
Omnia Medical PSiFDNA FDA UDI
Generic Name
Orthopaedic implant impactor, reusable FDA UDI
Device Name
PsiF DNA Impactor FDA UDI
Model / Reference
11-5P-IMP1-SS FDA UDI
Description
PsiF DNA Impactor FDA UDI

Identifiers

Catalog Number
11-5P-IMP1-SS FDA UDI
Primary DI / UDI-DI
00843511122775 FDA UDI
510(k) Number
K242431 FDA UDI
FDA Product Code
OUR FDA UDI
GMDN Term
Orthopaedic implant impactor, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3040 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

No

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: Orthopaedic implant impactor, reusable

Omnia Medical PSiFDNA by Omnia Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic implant impactor, reusable.

Cleared under the same submission

K242431 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Omnia Medical

Sources (1)

  • FDA UDI e72acfa7-dde0-4294-86bf-70c1fc1d94c4 36 fields · synced May 30, 2026