Rr Donnelley Gts Poland Sp Z O O

FDA Filings

This page includes the latest FDA filings for Rr Donnelley Gts Poland Sp Z O O. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3008606429
• FEI Number: 3008606429
• Name: RR Donnelley GTS Poland Sp. z o.o.
• Owner & Operator: RR Donnelley GTS Poland Sp. z o.o.
• Contact Address: Zakladowa 90/92 ; Lodz PL-NOTA 92-402 PL
• Official Correspondent:
  • Anna Srogosz
  • 48-42-2548110-x
• US Agent:
  • Kate Twomey
  • RR Donnelley
  • 713 1713354 1397
  • kate.twomey@rrd.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Zakladowa 90/92 ; Lodz Lodzkie, 92-402 PL
• Establishment Type:
  • Export Device to the United States But Perform No Other Operation on Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN P050020 | MDS RR Donnelley GTS Poland Sp. z o.o.	Navigator	2012-10-18
PMN K092602 | NBW RR Donnelley GTS Poland Sp. z o.o.	Flash 3	2012-10-18
PMN K092602 | LFR RR Donnelley GTS Poland Sp. z o.o.	Flash 3	2012-10-18
PMN K051213 | NBW RR Donnelley GTS Poland Sp. z o.o.	Xceed	2012-10-18
PMN K051213 | LFR RR Donnelley GTS Poland Sp. z o.o.	Xceed	2012-10-18
PMN K121087 | NBW RR Donnelley GTS Poland Sp. z o.o.	Contour Next USB	2012-09-26
PMN K120568 | NBW RR Donnelley GTS Poland Sp. z o.o.	Freestyle InsuLinx	2012-09-26
PMN K120568 | LFR RR Donnelley GTS Poland Sp. z o.o.	Freestyle InsuLinx	2012-09-26
PMN K111268 | NBW RR Donnelley GTS Poland Sp. z o.o.	Next EZ	2012-09-26
PMN K111268 | LFR RR Donnelley GTS Poland Sp. z o.o.	Next EZ	2012-09-26
PMN K111268 | JJX RR Donnelley GTS Poland Sp. z o.o.	Next EZ	2012-09-26
PMN K062058 | NBW RR Donnelley GTS Poland Sp. z o.o.	Reagent Strip;	2010-10-07
PMN K062058 | NBW RR Donnelley GTS Poland Sp. z o.o.	Ascensia Contour Blood Glucose Meter, Model 7151;	2010-10-07
PMN K062058 | LFR RR Donnelley GTS Poland Sp. z o.o.	Reagent Strip;	2010-10-07
PMN K062058 | LFR RR Donnelley GTS Poland Sp. z o.o.	Ascensia Contour Blood Glucose Meter, Model 7151;	2010-10-07

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2019032233419	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	LEAFLETS HS#490110	1 PCL
2018041035243	Bremerhaven,Federal Republic of Germany -> Norfolk, Virginia	FLYER HS#490110	1 PCL