KLS E-Coupling Adapter

FDA UDI

Class I (US FDA UDI)

by Pro-Dex, Inc.

Identity

Trade Name: KLS E-Coupling Adapter FDA UDI
Generic Name: Surgical power tool adaptor FDA UDI
Model / Reference: PDEC-1000-3 FDA UDI

Identifiers

Primary DI / UDI-DI: 00856482008016 FDA UDI
FDA Product Code: GEY FDA UDI
GXL FDA UDI
HWE FDA UDI
GMDN Term: Surgical power tool adaptor FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4820 FDA UDI
882.4900 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical power tool adaptor

KLS E-Coupling Adapter by Pro-Dex, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 I	Pending data

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Manufacturer

Manufacturer: Pro-Dex, Inc.

Sources (1)

FDA UDI 39fc0dd1-32e8-4815-8001-2cc92385f895 32 fields · synced Jun 8, 2026