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Adara

FDA UDI

Class II (US FDA UDI)

by Hnm Total Recon Llc

Identity

Trade Name
ADARA FDA UDI
Generic Name
Orthopaedic bone screw (non-sliding) FDA UDI
Device Name
ADARA ø4.5mm Cortical Screw, Full Thread, Self-Tap, SS - (L)20mm FDA UDI
Model / Reference
HTR-02-800920 FDA UDI
Description
ADARA ø4.5mm Cortical Screw, Full Thread, Self-Tap, SS - (L)20mm FDA UDI

Identifiers

Catalog Number
HTR-02-800920 FDA UDI
Primary DI / UDI-DI
00841742103099 FDA UDI
FDA Product Code
HWC FDA UDI
GMDN Term
Orthopaedic bone screw (non-sliding) 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

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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
MRI Safety
MR Safe FDA UDI

Category: Orthopaedic bone screw (non-sliding)

Adara by Hnm Total Recon Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic bone screw (non-sliding).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hnm Total Recon Llc

Sources (1)

  • FDA UDI 13b02e1c-2b8d-4c12-bfab-e19f78a8a7f7 34 fields · synced Jun 8, 2026