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Pulsar

FDA UDI

Class I (US FDA UDI)

by GS Medical Co., Ltd.

Identity

Trade Name
Pulsar FDA UDI
Generic Name
Orthopaedic surgical distractor, internal FDA UDI
Device Name
Shaver 8mm FDA UDI
Model / Reference
GS133-1258 FDA UDI
Description
Shaver 8mm FDA UDI

Identifiers

Catalog Number
GS133-1258 FDA UDI
Primary DI / UDI-DI
08806395408924 FDA UDI
FDA Product Code
HTR FDA UDI
GMDN Term
Orthopaedic surgical distractor, internal FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic surgical distractor, internal

Pulsar by GS Medical Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic surgical distractor, internal.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
GS Medical Co., Ltd.

Sources (1)

  • FDA UDI c341a8b5-fe41-40e3-bf2d-467a7e6622da 35 fields · synced May 30, 2026