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Shukla Copter S9COPTER

FDA UDI

Class I (US FDA UDI)

by Shukla Medical

Identity

Trade Name
Shukla Copter S9COPTER FDA UDI
Generic Name
Orthopaedic implant-instrument extension adaptor, reusable FDA UDI
Device Name
Extension Assy, 4" FDA UDI
Model / Reference
SXN007 FDA UDI
Description
Extension Assy, 4" FDA UDI

Identifiers

Primary DI / UDI-DI
BSXN0070 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Orthopaedic implant-instrument extension adaptor, 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

No

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

No

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 Conditional FDA UDI

Category: Orthopaedic implant-instrument extension adaptor, reusable

Shukla Copter S9COPTER by Shukla Medical — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic implant-instrument extension adaptor, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Shukla Medical

Sources (1)

  • FDA UDI e8662e1d-6f5b-4935-953f-2a97611081b3 34 fields · synced Jun 1, 2026