Custom MarkerStrand - Two Gold Marker preloaded in PSS1820SLS Round Hub Needle

FDA UDI

Class I (US FDA UDI)

by Eckert & Ziegler BEBIG GmbH

Identity

Trade Name: Custom MarkerStrand - Two Gold Marker preloaded in PSS1820SLS Round Hub Needle FDA UDI
Generic Name: Brachytherapy source spacer FDA UDI
Model / Reference: PSS1820SLS Round Hub Needle FDA UDI

Identifiers

Catalog Number: CMS0845SL3-1 FDA UDI
Primary DI / UDI-DI: 00815165020400 FDA UDI
FDA Product Code: IWJ FDA UDI
GMDN Term: Brachytherapy source spacer FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 892.5650 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Brachytherapy source spacer Manual brachytherapy system

Custom MarkerStrand - Two Gold Marker preloaded in PSS1820SLS Round Hub Needle by Eckert & Ziegler BEBIG GmbH — Class I — FDA UDI — listed in FDA GUDID

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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: Eckert & Ziegler BEBIG GmbH

Sources (1)

FDA UDI bb9e7312-2a01-4241-afe7-a4266079d9f7 34 fields · synced May 31, 2026