This page includes the latest FDA filings for Gelesis Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
Gelesis Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:
| Registration Number | 3012121794 |
| FEI Number | 3012121794 |
| Name | GELESIS INC |
| Owner & Operator | Gelesis Inc |
| Contact Address | 501 Boylston St Suite 6102 Boston MA 02116 US |
| Registration Status | 1 |
| Initial Importer | Y |
| Registration Expiration | 2020-04-25 |
| Registration Address | 501 Boylston St Suite 6102 Boston, MA 02116 US |
| Establishment Type | Complaint File Establishment per 21 CFR 820.198 |
Device Company | Device | Date |
|---|---|---|
| GELESIS, INC. | Plenity™ | 2020-05-14 |
| GELESIS, INC. | Plenity™ | 2020-03-17 |
GELESIS INC | Plenity | 2020-02-05 |
Gelesis, Inc. | Plenity | 2019-04-12 |
| NCAGE Code | 5GBV1 | GELESIS INC |
| CAGE Code | 5GBV1 | GELESIS INC |
| SEC | 0001385374 | Gelesis Inc of DELAWARE |
| Import ID | Shipment | Cargo Description | Quantity |
|---|---|---|---|
| 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 |
| 2020070914607 | Gioia Tauro,Italy -> Charleston, South Carolina | ON 10 PALLETS PLENITY POD LS/SN: P20121 - LS/ SN: P20125 - LS/SN: P20128 CUSTOMER ORDER NO. 2020-036 PO NO. 000097 DTD 05/05/2020 H.S. C ODE 3004 9000 EXPORTER GELESIS SRL FDA DEVICE LISTING NUMBER : D350892 IMPORTER GELESIS IN C FDA DEVICE LISTING NUMBER : D371267 DELIVER Y TERMS : CIF COOKEVILLE FREIGHT PREPAID | 80 CAS |