Custom MarkerStrand - Two Gold Marker preloaded in PSS1820SLS Round Hub Needle CMS0845SL3-1

GUDID 00815165020400

Eckert & Ziegler Bebig, Inc.

Brachytherapy source spacer
Primary Device ID00815165020400
NIH Device Record Keybb9e7312-2a01-4241-afe7-a4266079d9f7
Commercial Distribution StatusIn Commercial Distribution
Brand NameCustom MarkerStrand - Two Gold Marker preloaded in PSS1820SLS Round Hub Needle
Version Model NumberPSS1820SLS Round Hub Needle
Catalog NumberCMS0845SL3-1
Company DUNS021125001
Company NameEckert & Ziegler Bebig, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone203-262-0571
Emailned.lanfranco@bebig.com
Phone203-262-0571
Emailned.lanfranco@bebig.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100815165020400 [Primary]

FDA Product Code

IWJSystem, Applicator, Radionuclide, Manual

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2015-10-27

Devices Manufactured by Eckert & Ziegler Bebig, Inc.

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00815165020035 - AnchorLoad Brachytherapy Kit I125 - Loose Load2019-08-15
00815165020103 - Echo RTS Brachytherapy Kit2019-08-15
00815165020141 - EchoStrand Brachytherapy Kit I-1252019-08-15
00815165020172 - RTS Brachytherapy Kit I-1252019-08-15
00815165020189 - RTS Brachytherapy Kit PD1032019-08-15
00815165020240 - Spacer 5.5mm Synthetic 150 piece2019-08-15
00815165020271 - Spacer 5cm Synthetic 5 piece2019-08-15

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