FIRST WATER RAMSBURY LTD

FDA Device Registration & Listing · Marlborough Wiltshire, GB · Registration 9680731

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9680731
FEI Number
3002265219
Entity Name
FIRST WATER RAMSBURY LTD
City/State/Country
Marlborough Wiltshire, GB
Establishment Address
Hilldrop Lane, Ramsbury, Marlborough Wiltshire SN8 2RB, GB
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
GENTELL (Owner Number: 10026501)
Owner / Operator Contact Address
180 Rittenhouse Circle, Bristol, PA 19007, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

DE2LS/651/C1/1 - L-Mesitran Gentell Hydro 12cm x 8.5cm DE3LS/651/C1/1 - L-Mesitran Gentell Hydro 18cm x 12.5cm D3LS/651/C1/4 - L-Mesitran Hydro 10cm x 10cm D3LB/651/C1/4 - L-Mesitran Border 10cm x 10cm P3LB/651/C1/3 - Theraskin Active Large DE1LS/651/C1/1 - L-Mesitran Gentell Hydro 6cm x 6cm HC1515 Hydro Fiber Dressing 15x15cm / 6x6in GEN-15480 Bordered Gauze 4" x 8" GEN-19690 Sacral Silicone Superabsorbent Dressing DUP86266-9 - Xtrasorb Foam Adhesive DUP86144-9 - Xtrasorb Foam Non-Adhesive GEN-14700 Gentell Bordered Silicone Foam Sacral ; 9” x 9” GEN-14544 Gentell Waterproof Foam Dressing(Non-Bordered);4"x 4" DUP89533 Xtrasorb Super Absorbent Dressing Classic Non- Adhesive 3" X 3" DUP86144 Xtrasorb Super Absorbent Dressing Foam Non-Adhesive 4" X 4.75" GEN-14540 Gentell Split Drain Foam Dressing(Non-Bordered);4” x 5” GEN-15440 Gentell Split Drain Bordered Gauze; 4" GEN-14410 Gentell Circular Split Drain Foam Dressing; 4" GEN-15410 Gentell Bordered Gauze; 4" x 4'' GEN-13480 Gentell Calcium Alginate Dressing; 4" x 8" GEN-19420 Gentell Super Absorbent Adherent Dressing; 2" x 2" DUP86244 Xtrasorb Super Absorbent Dressing Foam Adhesive 4.5" X 4.5" GEN-13200 Gentell Calcium Alginate Dressing; 2" x 2" GEN-19640 Gentell Silicone Super Absorbent Dressing; 4"x4" GEN-19340 Gentell Super Absobent Dressing; 4"x 4" GEN-14400 Gentell Bordered Foam; 4" x 4" DUP89569 Xtrasorb Super Absorbent Dressing Classic Non- Adhesive 6" X 9" DUP88112 Algicell Calcium Alginate Dressing 3/4" x 12" GEN-19460 Gentell Superabsorbent Adherent Dressing 6" x 6" DUP86244-9 - Xtrasorb Foam Adhesive GEN-13040 Gentell CMC Fiber Dressing; 4" x 4" DUP86266 Xtrasorb Super Absorbent Dressing Foam Adhesive 6" X 6" DUP86188-9 - Xtrasorb Foam Non-Adhesive DUP88022 Algicell Calcium Alginate Dressing 2" x 2" DUP86233-9 - Xtrasorb Foam Adhesive DUP88100 Algicell Calcium Alginate Dressing 3/4" X 36" CFT2020 Polyurethane Foam Tracheostomy Dressing 20x20cm / 8x8in GEN-15610 Gentell Bordered Gauze; 6" x 6" GEN-15414 Gentell Silicone Bordered Gauze; 4"x4" GEN-14744 Gentell Bordered Silicone Foam; 4"x 4" GEN-19680 Gentell Silicone Super Absorbent Dressing; 8"x8" DUP86122 Xtrasorb Super Absorbent Dressing Foam Non-Adhesive 2" X 2" GEN13060 Gelling Fiber Dressing 6”x6” (15cmx15cm) DUP86388 Xtrasorb Super Absorbent Dressing HCS Non Adhesive 8" X 8" GEN13020 Gelling Fiber Dressing 2”x2” (5cmx5cm) GEN-14522 Gentell Waterproof Foam Dressing(Non-Bordered);2"x 2" A 0505 Calcium Alginate Dressing 5x5cm / 2x2in HC0505 Hydro Fiber Dressing 5x5cm / 2x2in GEN-19320 Gentell Super Absobent Dressing; 2"x 2" GEN-19350 Gentell Super Absobent Dressing; 5"x 5" CFT1010 Polyurethane Foam Tracheostomy Dressing 10x10cm / 4x4in GEN-13120 Gentell Calcium Alginate Dressing; 12" Rope CF1010 Polyurethane Foam Dressing 10x10cm / 4x4in DUP88048 Algicell Calcium Alginate Dressing 4" x 8" GEN-12400 Comfortell Composite Dressing; 4" x 4" GEN-11260 Gentell Acute Surgical Incisions Dressing DUP86433 Xtrasorb Super Absorbent Dressing HCS Adhesive 3" X 3" GEN-13020 Gentell CMC Fiber Dressing; 2" x 2" GEN-14766 Gentell Bordered Silicone Foam; 6"x 6" DUP86233 Xtrasorb Super Absorbent Dressing Foam Adhesive 3.2" X 3.2" GEN-19480 Gentell Super Absorbent Adherent Dressing; 8" x 8" GEN-13010 Gentell Calcium Alginate Dressing; 10" x 10" DUP86344 Xtrasorb Super Absorbent Dressing HCS Non Adhesive 4.5" X 4.5" DUP88044 Algicell Calcium Alginate Dressing 4" x 4" GEN-14600 Gentell Bordered Foam; 6" x 6" GEN-14777 Gentell Bordered Silicone Foam; 7"x 7" GEN-13500 Gentell Calcium Alginate Dressing; 4" x 4" GEN-13700 Gentell Calcium Alginate Dressing; 6" x 6" 61-89545 Xtrasorb Super Absorbent Dressing Classic Non- Adhesive 4" X 5" DUP86322 Xtrasorb Super Absorbent Dressing HCS Non Adhesive 2.3" X 2.3" GEN-12600 Comfortell Composite Dressing; 6" x 6" GEN-19380 Gentell Super Absobent Dressing; 8"x 8" DUP86188 Xtrasorb Super Absorbent Dressing Foam Non-Adhesive 8" X 8" GEN13040 Gelling Fiber Dressing 4”x4” (10cmx10cm) Lansinoh C section Hydrogel Pads DUP86122-9 - Xtrasorb Foam Non-Adhesive GEN-13060 Gentell CMC Fiber Dressing; 6" x 6" A 1010 Calcium Alginate Dressing 10x10cm / 4x4in GEN-19450 Gentell Super Absorbent Adherent Dressing; 5" x 5" GEN-14799 Gentell Bordered Silicone Foam; 9"x 9" DUP89545 Xtrasorb Super Absorbent Dressing Classic Non- Adhesive 4" X 5" DUP86466 Xtrasorb Super Absorbent Dressing HCS Adhesive 6" X 6" GEN-15616 Gentell Silicone Bordered Gauze; 6"x6" GEN-14588 Gentell Waterproof Foam Dressing(Non-Bordered); 8"x 8" GEN-14555 Gentell Waterproof Foam Dressing(Non-Bordered); 5"x 5" GEN-15810 Gentell Bordered Gauze; 8" x 8" GEN-15818 Gentell Silicone Bordered Gauze; 8"x8" GEN-19660 Gentell Silicone Super Absorbent Dressing; 6"x6" DUP89544 Xtrasorb Super Absorbent Dressing Classic Non- Adhesive 4" X 4" A 1020 Calcium Alginate Dressing 10x20cm / 4x8in CF060607 Polyurethane Foam Dressing 6x6cm / 3x3in 61-89569 Xtrasorb Super Absorbent Dressing Classic Non- Adhesive 6" X 9" HC1010 Hydro Fiber Dressing 10x10cm / 4x4in A 0230 Calcium Alginate Dressing 2x30cm / .8x12in MM0121 Gentell Fiber Dressing 5” x 5” (10cm x 12.5cm) (formerly MEDSAF 5” x 5” (10cm x 12.5cm)) A 1515 Calcium Alginate Dressing 15x15cm / 6x6in CF2020 Polyurethane Foam Dressing 20x20cm / 8x8in F12LB/648/C1/2 Dr Scholl's Blister Cushion Dressing F10LB/599/G2/2 Dr Scholl’s Corn Cushion - New Liner GEN-11130 Gentell Hydrogel Wound Dressing 3oz / 85g 73231-02 - Cutimed Hydrocontrol Curad “Soothe & Cool” Dressing (74 x 45mm) ZGIH44 HYDROGEL IMPREGNATED GAUZE DRESSING 4"X 4" Reliamed 6030-4157 - Glaciergel 61-53022 HYDROGEL IMPREGNATED GAUZE DRESSING 2"X 2" MCKESSON DUP81110 Aquasite Amorphous Hydrogel Dressings 1 fl oz Bellows G025 Amorphous Hydrogel with Alginate 1oz/25g Curad “Soothe & Cool” Dressing (56 x 26mm) GEN-11700 Gentell Hydrogel Sheet Dressing Borderless 7” x 5” (17.8cm x 12.7cm) DUP53044 Aquasite Impregnated Gauze Size 4" x 4" CWL 1004 - KerraLite Cool 6030-4156 - Glaciergel CWL 1008 - KerraLite Cool Border 73231-00 - Cutimed Hydrocontrol CBL-1212-118 12"X12" FOAM DRESSING BSN7261002- Cutimed Hydrogel 25 grams tube w/applicator 53022 Aquasite Impregnated Gauze Size 2" x 2" Medela Breast Pads (USA) CVS86433-9 Xtrasorb HCS Non-Adhesive 3"x3" (cvs) 73230-03 - Leukomed Control BSN7261001- Cutimed Hydrogel 15 grams tube w/applicator DUP86388-9 - Xtrasorb HCS Non-Adhesive DUP86433-9 - Xtrasorb HCS Non-Adhesive 53048 Aquasite Impregnated Gauze Size 4" x 8" 81110 HYDROGEL WOUND DRESSING 1 FL.OZ. MCKESSON Russell Chest Seal CWL 1009 - KerraLite Cool Border 73230-01 - Leukomed Control G085 Amorphous Hydrogel with Alginate 3oz/85g CWL 1007 - KerraLite Cool Border CWL 1005 - KerraLite Cool DH-03 Dermagran Hydrogel Wound Dressing 3oz DUP81122 Aquasite Hydrogel Impregnated Non-Woven Dressing 2" x 2" GEN-11470 Gentell Hydrogel Sheet Dressing Borderless 4.7” x 3.4” (12cm x 8.6cm) CBL-0206- 118 2"X 6" FOAM DRESSING DUP81144 Aquasite Hydrogel Impregnated Non-Woven Dressing 2" x 2" 73231-01 - Cutimed Hydrocontrol 61-53044 HYDROGEL IMPREGNATED GAUZE DRESSING 4"X 4" MCKESSON 73230-02 - Leukomed Control 73230-05 - Leukomed Control 73230-00 - Leukomed Control 40-2979 - Hydrogel Dressing DUP86344-9 Xtrasorb HCS 4.5"x4.5" CVS53022-4 CVS MOIST COOLING BURN PAD 2" X 2" GEN-11240 Gentell Hydrogel Sheet Dressing Borderless 2.4” x 2.4” (6cm x 6cm) CWL 1006 - KerraLite Cool 73231-03 - Cutimed Hydrocontrol DUP86466-9 - Xtrasorb HCS Adhesive DUP86322-9 Xtrasorb HCS 2.3"x2.3" DUP53048 Aquasite Impregnated Gauze Size 4" x 8" CBL-0404 - 118 4"X 4" FOAM DRESSING CBL-0808-118 8"X 8" FOAM DRESSING BSN7261000- Cutimed Hydrogel 8 grams tube w/applicator BSN7261003- Cutimed Hydrogel 15 grams tube

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FRO Dressing, Wound, Drug Unknown Class U N/A 2024-09-11
NAC Dressing, Wound, Hydrophilic General, Plastic Surgery Class 1 878.4018 2008-09-02
FMP Protector, Skin Pressure General Hospital Class 1 880.6450 2024-09-13
NAE Dressing, Wound, Hydrogel Without Drug And/Or Biologic General, Plastic Surgery Class 1 878.4022 2008-09-02

Official Correspondent

No official correspondent registered.

US Agent Details

Michael Alford Business: Gentell Email: malford@gentell.com Phone: (800) 8409041

Related Public Records

Same Entity

GENTELL
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
2530957 GENTELL Bristol, PA, US
9680091 DERMA SCIENCES CANADA, INC (dba DERMA SCIENCES, INC.) TORONTO Ontario, CA
3003636207 DERMA SCIENCES NANTONG INCORPORATION DEVELOPMENT Jiangsu, CN

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K150256 Argentum Medical SILVERLON BURN CONTACT DRESSINGS 2015-04-30

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0003-06 B. Braun Medical, Inc. U
D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025 3M Company Health Care Business 3m Center U
3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9680731. Last updated year: 2026. Please use registration number 9680731 when referencing this establishment in official correspondence.
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