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AURORA® Surgiscope®

FDA UDI

Class II (US FDA UDI)

by Rebound Therapeutics, Corporation

Identity

Trade Name
AURORA® Surgiscope® FDA UDI
Generic Name
Rigid optical intracranial/spinal endoscope, single-use FDA UDI
Device Name
AURORA® Surgiscope® System FDA UDI
Model / Reference
AS8/70 FDA UDI
Description
AURORA® Surgiscope® System FDA UDI

Identifiers

Catalog Number
AS8/70 FDA UDI
Primary DI / UDI-DI
00860624000462 FDA UDI
510(k) Number
K191861 FDA UDI
FDA Product Code
GWG FDA UDI
GTZ FDA UDI
GMDN Term
Rigid optical intracranial/spinal endoscope, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1480 FDA UDI
866.3740 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Length — 70 Millimeter FDA UDI

Category: Rigid optical intracranial/spinal endoscope, single-use

AURORA® Surgiscope® by Rebound Therapeutics, Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Rigid optical intracranial/spinal endoscope, single-use.

Cleared under the same submission

K191861 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Rebound Therapeutics, Corporation

Sources (1)

  • FDA UDI e57f4772-9f59-4f59-aef7-86e2a0e2f717 37 fields · synced Jun 8, 2026