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Precept

FDA UDI

Class II (US FDA UDI)

by Nuvasive, Inc.

Identity

Trade Name
Precept FDA UDI
Generic Name
Fascial tissue dilator, reusable FDA UDI
Device Name
PRECEPT Dilator, Reduction Screw FDA UDI
Model / Reference
8801296 FDA UDI
Description
PRECEPT Dilator, Reduction Screw FDA UDI

Identifiers

Primary DI / UDI-DI
00887517352194 FDA UDI
510(k) Number
K112709 FDA UDI
FDA Product Code
ETN FDA UDI
GMDN Term
Fascial tissue dilator, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.1820 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: Fascial tissue dilator, reusable

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

Similar devices

Also classified as Fascial tissue dilator, reusable.

Cleared under the same submission

K112709 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nuvasive, Inc.

Sources (1)

  • FDA UDI be147460-3d5d-48fb-a9f0-55b3bc331cee 35 fields · synced Jun 8, 2026