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CoRoent

FDA UDI

Class I (US FDA UDI)

by Nuvasive, Inc.

Identity

Trade Name
CoRoent FDA UDI
Generic Name
Internal spinal fixation procedure kit, single-use FDA UDI
Device Name
CoRoent SI Drill Bit, 2.0x12mm FDA UDI
Model / Reference
6790151P FDA UDI
Description
CoRoent SI Drill Bit, 2.0x12mm FDA UDI

Identifiers

Primary DI / UDI-DI
00195377006448 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Internal spinal fixation procedure kit, 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

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Radiation Sterilization FDA UDI

Category: Internal spinal fixation procedure kit, single-use

CoRoent by Nuvasive, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Internal spinal fixation procedure kit, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nuvasive, Inc.

Sources (1)

  • FDA UDI fcbddd78-91b0-4c6d-acd8-50fa653450bb 34 fields · synced May 30, 2026