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Discectomy Set

FDA UDI

Class I (US FDA UDI)

by Spineology Inc.

Identity

Trade Name
Discectomy Set FDA UDI
Generic Name
Viscera retention paddle FDA UDI
Device Name
3x7mm Introducer Paddle FDA UDI
Model / Reference
15-02-05 FDA UDI
Description
3x7mm Introducer Paddle FDA UDI

Identifiers

Catalog Number
303-0115 FDA UDI
Primary DI / UDI-DI
M7403030115 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Viscera retention paddle 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
MRI Safety
MR Unsafe FDA UDI

Category: Viscera retention paddle

Discectomy Set by Spineology Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Viscera retention paddle.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spineology Inc.

Sources (1)

  • FDA UDI 92d4db08-6ca0-4b50-a4d3-ed92e1f508a9 35 fields · synced Jun 1, 2026