This page includes the latest FDA filings for Gentell. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 2530957 |
| FEI Number | 1000522686 |
| Name | GENTELL |
| Owner & Operator | GENTELL |
| Contact Address | 2701 Bartram Road Bristol PA 19007 US |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | Y |
| Registration Expiration | 2020-04-25 |
| Registration Address | 2701 Bartram Rd Bristol, PA 19007 US |
| Establishment Type |
|
Device Company | Device | Date |
|---|---|---|
| Gentell, Gentell, Inc. | Otc Medication | 2020-06-10 |
| Gentell, Gentell, Inc. | Otc Medication | 2020-05-13 |
| Gentell, Gentell, Inc. | Otc Medication | 2020-05-12 |
| Gentell | Hand Sanitizer | 2020-05-08 |
GENTELL | Gentell Collagen Wound Dressing; Particles, 2"x2" and 4"x5.25" | 2017-03-15 |
GENTELL | Gentell Collagen Wound Dressing: 4"x4", 7"x7" | 2017-03-15 |
GENTELL | Gentell Hydrogel Saturated Dressings; 2"x2", 4"x4", 4"x8" | 2008-09-02 |
GENTELL | Gentell Hydrogel 8oz Spray Bottle | 2008-09-02 |
GENTELL | Gentell Hydrogel 4oz Tube | 2008-09-02 |
GENTELL | Gentell Honey Hydrogel Saturated Dressings; 2"x2", 4"x4", 4"x8" | 2008-09-02 |
GENTELL | Gentell Honey Hydrogel 4oz Tube | 2008-09-02 |
GENTELL | Gentell Xeroform Petrolatum Dressing; 5 | 2008-09-02 |
GENTELL | Gentell Xeroform Petrolateum Dressing 2"x2", 5"x9" | 2008-09-02 |
GENTELL | Gentell Petrolatum Gauze Dressing; 3"x9" | 2008-09-02 |
GENTELL | Gentell Oil Emulsion Dressing; 3"x3" | 2008-09-02 |
GENTELL | Gentell MVP Transparent Dressing | 2008-09-02 |
GENTELL | Gentell Honey Gauze Dressing; 4"x4" | 2008-09-02 |
GENTELL | Dermatell Non-Bordered Hydrocolloid Dressing; 4"x4" | 2008-09-02 |
GENTELL | Dermatell Hydrocolloid Dressing with Border; 4"x4", 6"x6" | 2008-09-02 |
GENTELL | Gentell Waterproof Foam Dressings 2"x2", 4"x4", 5"x5", 8"x8" | 2008-09-02 |
GENTELL | Gentell Super Absorbent Dressing Adherent 2"x2", 5"x5", 8"x8" | 2008-09-02 |
GENTELL | Gentell Super Absorbent Dressing 2"x2", 4"x4", 5"x5", 8"x8" | 2008-09-02 |
GENTELL | Gentell Silicone Bordered Foam Dressing. 4"x4", 6"x6" | 2008-09-02 |
GENTELL | Gentell LoProfile Plus Non-Bordered Split Foam Dressing; 4"x5" | 2008-09-02 |
GENTELL | Gentell LoProfile Bordered Foam Dressing; 4"x4" , 6"x6" | 2008-09-02 |
GENTELL | Gentell Honey Alginate Dressing, 2"x2", 4.5"x4.5" | 2008-09-02 |
GENTELL | Gentell Calcium Alginate Dressing; 2"x2", 4"x4", 5"x5", 12" Rope | 2008-09-02 |
GENTELL | Gentell Calcium Alginate Dressing with Silver; 2"x2", 4"x4", 4.5"x4.5", 8"x8" and 12" Rope | 2008-09-02 |
GENTELL | Gentell Calcium Alginate 10"x10" | 2008-09-02 |
GENTELL | Gentell CMC Fiber Dressing 2"x2", 4"x4", 5"x5" | 2008-09-02 |
GENTELL | Gentell Bordered Foam Dressing Ag 4"x 4", 6"x6" | 2008-09-02 |
GENTELL | Genell LoProfile Plus Fenestrated Foam Dressing 4" Circular | 2008-09-02 |
GENTELL | Gentell Rolled Gauze Bandage 4.5" x 4.1 YDS | 2008-09-02 |
GENTELL | Gentell Conforming Stretch Gauze 3" x 75" | 2008-09-02 |
GENTELL | Gentell Comfortell Wound Dressing | 2008-09-02 |
GENTELL | Gentell Comfortell Dressing; 4"x4", 6"x6" | 2008-09-02 |
GENTELL | Gentell Bordered Gauze; 4"x4", 6"x6", 8"x8" | 2008-09-02 |
GENTELL | Circular Split Drain Gauze 4" Circular | 2008-09-02 |
GENTELL | Gentell FixTape 4" x 11 yards | 2008-09-02 |
GENTELL | Gentell Fix Tape;,2"x11 yards | 2008-09-02 |
GENTELL | Gentell Comfortell Dressing; 4"x4", 6"x6" | 2008-09-02 |
GENTELL | GENTELL HYDROGEL SPRAY GEL, APPLIGARD SQUEEZE | 1999-08-12 |
| Import ID | Shipment | Cargo Description | Quantity |
|---|---|---|---|
| 2020082018773 | Shanghai ,China (Mainland) -> New York/Newark Area, Newark, New Jersey | COTTON GAUZE BANDAGE ROLL | 528 CTN |
| 2020082018786 | Shanghai ,China (Mainland) -> New York/Newark Area, Newark, New Jersey | FOAM BORDERED DRESSING | 445 CTN |
| 2020081848564 | Haifa,Israel -> New York/Newark Area, Newark, New Jersey | SACHET | 1222 CAS |
| 202006106619 | Wuhan,China (Mainland) -> New York/Newark Area, Newark, New Jersey | FOAM BORDERED DRESSING 440 CARTONS(19 PALLETS . | 440 CTN |
| 202003046057 | Wuhan,China (Mainland) -> New York/Newark Area, Newark, New Jersey | FOAM BORDERED DRESSING 326 CARTONS(9 PALLETS) | 326 CTN |
| 202001076618 | Wuhan,China (Mainland) -> New York/Newark Area, Newark, New Jersey | COTTON GAUZE BANDAGE ROLL, BANDAGE 548CARTONS ADDRESS JFREDERICO@GENTELL.COM | 548 CTN |
| 201911048789 | Tsingtao,China (Mainland) -> New York/Newark Area, Newark, New Jersey | WOUND DRESSING | 84 CTN |
| 2019072711624 | Tsingtao,China (Mainland) -> New York/Newark Area, Newark, New Jersey | WOUND DRESSING 2X2' | 50 CTN |