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Construct ™

FDA UDI

Class I (US FDA UDI)

by Ascension Orthopedics, Inc.

Identity

Trade Name
Construct ™ FDA UDI
Generic Name
Surgical drill guide, reusable FDA UDI
Device Name
Construct® Ankle Fusion Plate System The guide pin targeting sleeve is attached to the guide pin targeting base in the Construct Ankle Fusion Plate System. FDA UDI
Model / Reference
GTS-1000-01 FDA UDI
Description
Construct® Ankle Fusion Plate System The guide pin targeting sleeve is attached to the guide pin targeting base in the Construct Ankle Fusion Plate System. FDA UDI

Identifiers

Catalog Number
GTS100001 FDA UDI
Primary DI / UDI-DI
10381780245407 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Surgical drill guide, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 FDA UDI
Commercial Distribution
Not 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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Construct ™ by Ascension Orthopedics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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 080d41cc-e123-4298-bbd4-53cc01c86bc4 37 fields · synced May 30, 2026