FDA Registration
Active
🇺🇸 United States
GEN-19460 Gentell Superabsorbent Adherent Dressing 6" x 6"
Reg #: 2530957
·
FEI: 1000522686
·
Expires 2025
Products
1
Proprietary Names
68
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- GENTELL
- Registration Number
- 2530957
- FEI Number
- 1000522686
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 180 Rittenhouse Circle
- City
- Bristol
- State
- PA
- ZIP
- 19007
- Country
- US
Owner / Operator
- Firm Name
- GENTELL
- Operator Number
- 10026501
- Address
- 180 Rittenhouse Circle,
- City
- Bristol
- State
- PA
- Postal Code
- 19007
- Country
- US
- Correspondent
- Michael Alford
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2008-09-02 |
Proprietary Names
GEN-19460 Gentell Superabsorbent Adherent Dressing 6" x 6"
GEN-14766 Gentell Bordered Silicone Foam; 6"x 6"
DUP86144 Xtrasorb Super Absorbent Dressing Foam Non-Adhesive 4" X 4.75"
GEN-13040 Gentell CMC Fiber Dressing; 4" x 4"
DUP86244 Xtrasorb Super Absorbent Dressing Foam Adhesive 4.5" X 4.5"
GEN-15610 Gentell Bordered Gauze; 6" x 6"
GEN-15414 Gentell Silicone Bordered Gauze; 4"x4"
DUP86188 Xtrasorb Super Absorbent Dressing Foam Non-Adhesive 8" X 8"
GEN-14400 Gentell Bordered Foam; 4" x 4"
DUP86433 Xtrasorb Super Absorbent Dressing HCS Adhesive 3" X 3"
GEN-15410 Gentell Bordered Gauze; 4" x 4''
GEN-13480 Gentell Calcium Alginate Dressing; 4" x 8"
DUP86466 Xtrasorb Super Absorbent Dressing HCS Adhesive 6" X 6"
DUP88044 Algicell Calcium Alginate Dressing 4" x 4"
DUP86233-9 - Xtrasorb Foam Adhesive
DUP86144-9 - Xtrasorb Foam Non-Adhesive
GEN-19480 Gentell Super Absorbent Adherent Dressing; 8" x 8"
DUP86233 Xtrasorb Super Absorbent Dressing Foam Adhesive 3.2" X 3.2"
GEN-13500 Gentell Calcium Alginate Dressing; 4" x 4"
GEN-13700 Gentell Calcium Alginate Dressing; 6" x 6"
GEN-13060 Gentell CMC Fiber Dressing; 6" x 6"
GEN-19320 Gentell Super Absobent Dressing; 2"x 2"
DUP86266-9 - Xtrasorb Foam Adhesive
DUP86122-9 - Xtrasorb Foam Non-Adhesive
GEN-14588 Gentell Waterproof Foam Dressing(Non-Bordered); 8"x 8"
GEN-14555 Gentell Waterproof Foam Dressing(Non-Bordered); 5"x 5"
DUP86244-9 - Xtrasorb Foam Adhesive
GEN-14522 Gentell Waterproof Foam Dressing(Non-Bordered);2"x 2"
GEN-13200 Gentell Calcium Alginate Dressing; 2" x 2"
GEN-15810 Gentell Bordered Gauze; 8" x 8"
GEN-14600 Gentell Bordered Foam; 6" x 6"
GEN-14744 Gentell Bordered Silicone Foam; 4"x 4"
GEN-19680 Gentell Silicone Super Absorbent Dressing; 8"x8"
GEN-19350 Gentell Super Absobent Dressing; 5"x 5"
DUP89544 Xtrasorb Super Absorbent Dressing Classic Non- Adhesive 4" X 4"
DUP86322 Xtrasorb Super Absorbent Dressing HCS Non Adhesive 2.3" X 2.3"
GEN-15616 Gentell Silicone Bordered Gauze; 6"x6"
GEN-19420 Gentell Super Absorbent Adherent Dressing; 2" x 2"
GEN-15440 Gentell Split Drain Bordered Gauze; 4"
GEN-14410 Gentell Circular Split Drain Foam Dressing; 4"
DUP88048 Algicell Calcium Alginate Dressing 4" x 8"
DUP88112 Algicell Calcium Alginate Dressing 3/4" x 12"
DUP88022 Algicell Calcium Alginate Dressing 2" x 2"
GEN-13010 Gentell Calcium Alginate Dressing; 10" x 10"
GEN-14540 Gentell Split Drain Foam Dressing(Non-Bordered);4 x 5
DUP89545 Xtrasorb Super Absorbent Dressing Classic Non- Adhesive 4" X 5"
GEN-12400 Comfortell Composite Dressing; 4" x 4"
GEN-19450 Gentell Super Absorbent Adherent Dressing; 5" x 5"
GEN-14799 Gentell Bordered Silicone Foam; 9"x 9"
GEN-14777 Gentell Bordered Silicone Foam; 7"x 7"
GEN-19640 Gentell Silicone Super Absorbent Dressing; 4"x4"
GEN-19340 Gentell Super Absobent Dressing; 4"x 4"
DUP89533 Xtrasorb Super Absorbent Dressing Classic Non- Adhesive 3" X 3"
GEN-12600 Comfortell Composite Dressing; 6" x 6"
GEN-14544 Gentell Waterproof Foam Dressing(Non-Bordered);4"x 4"
DUP86122 Xtrasorb Super Absorbent Dressing Foam Non-Adhesive 2" X 2"
GEN-13120 Gentell Calcium Alginate Dressing; 12" Rope
GEN-14700 Gentell Bordered Silicone Foam Sacral ; 9 x 9
DUP86388 Xtrasorb Super Absorbent Dressing HCS Non Adhesive 8" X 8"
DUP89569 Xtrasorb Super Absorbent Dressing Classic Non- Adhesive 6" X 9"
GEN-15818 Gentell Silicone Bordered Gauze; 8"x8"
GEN-19660 Gentell Silicone Super Absorbent Dressing; 6"x6"
DUP88100 Algicell Calcium Alginate Dressing 3/4" X 36"
DUP86266 Xtrasorb Super Absorbent Dressing Foam Adhesive 6" X 6"
GEN-13020 Gentell CMC Fiber Dressing; 2" x 2"
DUP86188-9 - Xtrasorb Foam Non-Adhesive
DUP86344 Xtrasorb Super Absorbent Dressing HCS Non Adhesive 4.5" X 4.5"
GEN-19380 Gentell Super Absobent Dressing; 8"x 8"
Establishment Types
Manufacture Medical Device