ASTRA Spine System

FDA UDI

Class II (US FDA UDI)

by Spinecraft Llc

Identity

Trade Name: ASTRA Spine System FDA UDI
Generic Name: Stereotactic surgery system probe, reusable FDA UDI
Device Name: ASTRA Cannulated Dia. 7.00mm Tap - Navigated FDA UDI
Model / Reference: 6300-71-70N FDA UDI
Description: ASTRA Cannulated Dia. 7.00mm Tap - Navigated FDA UDI

Identifiers

Catalog Number: 6300-71-70N FDA UDI
Primary DI / UDI-DI: 00193082154379 FDA UDI
FDA Product Code: OLO FDA UDI
GMDN Term: Stereotactic surgery system probe, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.4560 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Stereotactic surgery system probe, reusable

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

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Spinecraft Llc

Sources (1)

FDA UDI 7e01aaf9-e6e7-44f6-9e63-b7ae53595798 35 fields · synced Jun 6, 2026