Gelesis S R L

FDA Filings

This page includes the latest FDA filings for Gelesis S R L. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3012121187
• FEI Number: 3012121187
• Name: Elaine Chiquette
• Owner & Operator: Gelesis srl
• Contact Address: Via Verdi, 188 ; Calimera (LE) IT-LE Lecce 73021 IT
• Official Correspondent:
  • Cosimo Saponaro
  • 39-08-32872749-x
• US Agent:
  • Elaine Chiquette
  • Gelesis Inc
  • 858 2324592
  • echiquette@gelesis.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 501 Boylston St. Suite 6102 ; Boston, MA 02116 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN DEN180060 | QFQ Elaine Chiquette [Gelesis srl]	Plentiy	2019-06-07

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020091133358	Napoli,Italy -> Charleston, South Carolina	124 CASES ON 16 PALLETS PLENITY POD LOT NO. P 20181 - P20186 - P20190 - P20194 PO NO. 00001 04 DTD 7/30/2020 CUSTOMER ORDER NO. 2020-053 EXPORTER GELESIS SRL FDA DEVICE LISTING NUMBE R : D350892 IMPORTER GELESIS INC FDA DEVICE L ISTING NUMBER : D371267 DELIVERY TERMS : CIF COOKEVILLE FREIGHT PREPAID TEMPERATURE : 15,0	124 PKG
2020091028885	Napoli,Italy -> Charleston, South Carolina	124 CASES ON 16 PALLETS PLENITY POD LOT NO. P 20181 - P20186 - P20190 - P20194 PO NO. 00001 04 DTD 7/30/2020 CUSTOMER ORDER NO. 2020-053 EXPORTER GELESIS SRL FDA DEVICE LISTING NUMBE R : D350892 IMPORTER GELESIS INC FDA DEVICE L ISTING NUMBER : D371267 DELIVERY TERMS : CIF COOKEVILLE FREIGHT PREPAID TEMPERATURE : 15,0	124 PKG
2020082418476	Napoli,Italy -> Charleston, South Carolina	PLENITY POD 120 CASES ON 15 PALLETS LOT NO. P 20164 - P20167 - P20171 - P20177 PO NO. 00010 0 DTD 06/15/2020 CUSTOMER ORDER NO. 2020-043 EXPORTER GELESIS SRL FDA DEVICE LISTING NUMBE R : D350892 IMPORTER GELESIS INC FDA DEVICE L ISTING NUMBER : D371267 DELIVERY TERMS : CIF COOKEVILLE FREIGHT PREPAID TEMPERATURE : 15,0	120 PKG
2020072420692	Napoli,Italy -> Charleston, South Carolina	ON 10 PALLETS PLENITY POD LOT NO. P20132 - P2 0135 - P20140 PO NO. 000100 DTD 06/15/2020 CU STOMER ORDER NO. 2020-043 H.S. CODE : 3004 90 00 EXPORTER GELESIS S.R.L. FDA DEVICE LISTING NUMBER : D350892 IMPORTER GELESIS I.N.C. FDA DEVICE LISTING NUMBER : D371267 DELIVERY TER MS : CIF COOKEVILLE FREIGHT PREPAID TEMPERATU	75 CAS