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Spacemaker

FDA UDI

Class II (US FDA UDI)

by Covidien LP

Identity

Trade Name
Spacemaker FDA UDI
Generic Name
Laparoscopic balloon dissector FDA UDI
Device Name
Access and Dissector System FDA UDI
Model / Reference
SMBTTOVLX FDA UDI
Description
Access and Dissector System FDA UDI

Identifiers

Primary DI / UDI-DI
10884521545298 FDA UDI
510(k) Number
K151356 FDA UDI
FDA Product Code
GCJ FDA UDI
GMDN Term
Laparoscopic balloon dissector FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Laparoscopic balloon dissector

Spacemaker by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Laparoscopic balloon dissector.

Cleared under the same submission

K151356 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Covidien LP

Sources (1)

  • FDA UDI 8879397a-45b3-435b-bb77-1f6526383ed5 36 fields · synced Jun 8, 2026