Edm

FDA UDI

Class II (US FDA UDI)

by Medtronic PS Medical

Identity

Trade Name: EDM FDA UDI
Generic Name: Medical device service rail clamp FDA UDI
Device Name: CLAMP 46135 QUICK ATTACH POLE FDA UDI
Model / Reference: 46135 FDA UDI
Description: CLAMP 46135 QUICK ATTACH POLE FDA UDI

Identifiers

Primary DI / UDI-DI: 00643169497603 FDA UDI
510(k) Number: K983799 FDA UDI
FDA Product Code: JXG FDA UDI
GWM FDA UDI
GMDN Term: Medical device service rail clamp FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.5550 FDA UDI
882.1620 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Dimensions & Sizes

Size: Length — 2.98 Inch FDA UDI

Category: Medical device service rail clamp

Edm by Medtronic PS Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Medical device service rail clamp.

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RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
Bracket — LivaNova USA, Inc. · Class I
Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC. · Class I
Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC. · Class I
CAPIOX — Terumo Corp. · Class I

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Medtronic PS Medical

Sources (1)

FDA UDI 8b086fe7-c2af-44a5-ad97-dee3ed282437 36 fields · synced Jun 6, 2026