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Rampart-O

FDA UDI

Class I (US FDA UDI)

by Spineology Inc.

Identity

Trade Name
Rampart-O FDA UDI
Generic Name
Orthopaedic implant impactor, reusable FDA UDI
Device Name
Slap Mallet Extension FDA UDI
Model / Reference
83-05-04 FDA UDI
Description
Slap Mallet Extension FDA UDI

Identifiers

Catalog Number
270-0021 FDA UDI
Primary DI / UDI-DI
M7402700021 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Orthopaedic implant impactor, 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
MRI Safety
MR Unsafe FDA UDI

Category: Orthopaedic implant impactor, reusable

Rampart-O by Spineology Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic implant impactor, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spineology Inc.

Sources (1)

  • FDA UDI f484deb3-3044-426d-b4ed-a8b1661a48c0 35 fields · synced Jun 6, 2026