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General Instruments

FDA UDI

Class I (US FDA UDI)

by Alphatec Spine, Inc.

Identity

Trade Name
General Instruments FDA UDI
Generic Name
Radiological image marker, noninvasive, reusable FDA UDI
Device Name
Extra Long Pedicle Marker, Left FDA UDI
Model / Reference
CI-10599-10 FDA UDI
Description
Extra Long Pedicle Marker, Left FDA UDI

Identifiers

Primary DI / UDI-DI
00840180500057 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Radiological image marker, noninvasive, reusable 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

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Radiological image marker, noninvasive, reusable

General Instruments by Alphatec Spine, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiological image marker, noninvasive, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Alphatec Spine, Inc.

Sources (1)

  • FDA UDI 1c18b9b6-f42c-4cd4-b942-c3b1ebe39bc2 34 fields · synced Jun 8, 2026