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ASTRA-OCT Spine System

FDA UDI

Class I (US FDA UDI)

by Spinecraft Llc

Identity

Trade Name
ASTRA-OCT Spine System FDA UDI
Generic Name
General internal orthopaedic fixation system implantation kit FDA UDI
Device Name
ASTRA-OCT Depth Gage FDA UDI
Model / Reference
6600-93B FDA UDI
Description
ASTRA-OCT Depth Gage FDA UDI

Identifiers

Catalog Number
6600-93B FDA UDI
Primary DI / UDI-DI
00193082153921 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
General internal orthopaedic fixation system implantation kit 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: General internal orthopaedic fixation system implantation kit

ASTRA-OCT Spine System by Spinecraft Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General internal orthopaedic fixation system implantation kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spinecraft Llc

Sources (1)

  • FDA UDI ebbdece5-c784-46bb-8887-2a8e2a89f11a 35 fields · synced May 30, 2026