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Draco

FDA UDI

Class II (US FDA UDI)

by Hnm Total Recon Llc

Identity

Trade Name
DRACO FDA UDI
Generic Name
External orthopaedic fixation system, single-use FDA UDI
Device Name
DRACO MetaFuse L-Plate, Ti - (L)28mm, R FDA UDI
Model / Reference
HTR-03-010728 FDA UDI
Description
DRACO MetaFuse L-Plate, Ti - (L)28mm, R FDA UDI

Identifiers

Catalog Number
HTR-03-010728 FDA UDI
Primary DI / UDI-DI
00841742121789 FDA UDI
FDA Product Code
KTT FDA UDI
GMDN Term
External orthopaedic fixation system, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3030 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

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: External orthopaedic fixation system, single-use

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

Similar devices

Also classified as External orthopaedic fixation system, single-use.

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 149be42f-cd32-453e-8eb9-33a0e985e77a 34 fields · synced Jun 6, 2026