EBSL-5
Lidocaine Hydrochloride
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1219592 | 1219592 | Water-Jel Technologies, LLC | 1 | N | 2026-01-01 | 13359 Reese Blvd. E Huntersville NC US 28078 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00743537000449 | First Responder - 12"X16" Burn Dressing First Responder, 2 boxes of 10; BD Gel HA | 855-428-6074 | sales@safeguardmedical.com |
| 00743537000456 | First Responder - "12""X16"" Burn Dressing First Responder, 2 boxes of 10; BD Gel HA" | 855-428-6074 | sales@safeguardmedical.com |
| 00743537000470 | Military - "HA Military 4""x16"" Burn Dressing (28pcs/cs); BD Gel HA" | 855-428-6074 | sales@safeguardmedical.com |
| 00743537000715 | Military - HA Military 4"x16" Burn Dressing (28pcs/cs); BD Gel HA | 855-428-6074 | sales@safeguardmedical.com |
| 00743537000869 | Water-Jel - BJ HA Unit Dose German 1728/cs; BD Gel | 855-428-6074 | sales@safeguardmedical.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 1439 | 2003738102 | K990180 | BURNFREE (4X4, 8X8, 16X24) STERILE BURN & WOUND DRESSING | MGQ | 1999-08-13 |
| 1439 | 1024294925 | K990178 | BURNFREE PAIN RELIEVING GEL, MODEL 4B | MGQ | 1999-08-13 |
| 1439 | 1017437820 | K955506 | HYCURE | KGN | 1996-01-17 |
| 1439 | 1876436862 | K952561 | WATER JEL BURN KIT | LRR | 1995-07-14 |
| 1439 | 1719188640 | K900516 | WATER JEL STERILE GEL-SOAKED BURN DRESSING | FRO | 1990-03-19 |
| 1439 | 1527104391 | K800064 | WATER JEL FIRE BLANKET | FPY | 1980-03-25 |
| 1439 | 1819915456 | K150074 | Elevate Moisturizing Spray | LFD | 2015-06-19 |
| 1439 | 1726223911 | K132891 | HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER | FRO | 2014-06-19 |
| 1439 | 1354246850 | K131376 | SMARTCOAT 2.5% NAF VARNISH | LBH | 2013-08-27 |
| 1439 | 1814605500 | K093620 | PULPDENT FLUORIDE VARNISH | LBH | 2010-03-10 |
| 1439 | 1782655931 | K061227 | HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER | FRO | 2006-12-20 |
| 1439 | 1500544830 | K003396 | BURN JEL PLUS | MGQ | 2001-01-11 |
| 1439 | 1091321908 | ||||
| 1439 | 1331582711 | ||||
| 1439 | 1642042689 | ||||
| 1439 | 1895029385 |
Lidocaine Hydrochloride
Lidocaine Hydrochloride
Lidocaine Hydrochloride
Lidocaine Hydrochloride
Lidocaine Hydrochloride
Lidocaine Hydrochloride
Benzalkonium chloride
Isopropyl Alcohol
Hydrogen Peroxide
Alcohol
Lidocaine hydrochloride
Lidocaine hydrochloride
Bacitracin
First Aid Ointment
Bacitracin zinc, Polymyxin B Sulfate, Neomycin Sulfate
Anti-itch cream
Menthol
Benzalkonium Chloride, Lidocaine Hydrochloride
Benzalkonium Chloride, Lidocaine Hydrochloride
WATER-JEL TECHNOLOGIES, LLC.
WATER-JEL TECHNOLOGIES, INC.
2026-02-19
2026-02-19
2026-02-19
2026-02-19
2024-11-01
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2024-10-31
2024-10-31
2024-10-29
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2024-10-25