FDA.reportPublic FDA data

Wound hydrogel dressing, non-antimicrobial

Definition
A wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases; it does not include an antimicrobial agent(s). This is a single-use device.
GUDID devices
486
Last updated
2026-10-15 14:55:32

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
04049500834919HydroTac transparent 5cmx7,5cm st P10PAUL HARTMANN AG685900 HydroTac transparent 5cmx7,5cm st P102020-09-01
04049500834940HydroTac transparent 10cmx10cm st P10PAUL HARTMANN AG685901 HydroTac transparent 10cmx10cm st P102020-09-01
04049500834971HydroTac transparent 10x20cm st P10 C6PAUL HARTMANN AG685902 HydroTac transparent 10x20cm st P10 C62020-09-01
04049500835008HydroTac transparent 20x20cm st P10PAUL HARTMANN AG685903 HydroTac transparent 20x20cm st P102020-09-01
04049500835039HydroTac transparent comf. 8x8cm st P10PAUL HARTMANN AG685920 HydroTac transparent comf. 8x8cm st P102020-09-01
04049500835060HydroTac transp.comf. 12,5x12,5cm st P10PAUL HARTMANN AG685921 HydroTac transp.comf. 12,5x12,5cm st P102020-09-01
04049500835091HydroTac transp. comf. 10x20cm st P10PAUL HARTMANN AG685922 HydroTac transp. comf. 10x20cm st P102020-09-01
04049500835121HydroTac transp. comf. 6,5x10cm st P10PAUL HARTMANN AG685923 HydroTac transp. comf. 6,5x10cm st P102020-09-01
04052199273501HydroTac transparent 5x7,5cm steril P10PAUL HARTMANN AG685905 HydroTac transparent 5x7,5cm steril P102020-09-01
04052199273563HydroTac transp. comfort 8x8cm st P10PAUL HARTMANN AG685925 HydroTac transp. comfort 8x8cm st P102020-09-01
04052199273600HydroTac transp. comf.12,5x12,5cm st P10PAUL HARTMANN AG685926 HydroTac transp. comf.12,5x12,5cm st P102020-09-01
04052199273648HydroTac transp. comf. 10x20cm st P10PAUL HARTMANN AG685927 HydroTac transp. comf. 10x20cm st P102020-09-01
04052199273686HydroTac transp. comf. 6,5x10cm st P10PAUL HARTMANN AG685928 HydroTac transp. comf. 6,5x10cm st P102020-09-01
04052199274201HydroTac transparent 10x10cm steril P10PAUL HARTMANN AG685906 HydroTac transparent 10x10cm steril P102020-09-01
04052199274249HydroTac transparent 10x20cm steril P10PAUL HARTMANN AG685907 HydroTac transparent 10x20cm steril P102020-09-01
04052199274287HydroTac transparent 20x20cm steril P10PAUL HARTMANN AG685908 HydroTac transparent 20x20cm steril P102020-09-01
00841277111248Novera BalanceHarps USA, Inc.NVHYGE025G2026-09-04
04042809394429Cutimed®BSN medical GmbH72610-032022-12-08
00850060751738SkinPenBellus Medical, LLCF5SP5812026-05-20
08809319802631HyFer HerNonMOON-X USA, Inc.Neo HC gel 5HP2026-08-03
00714196322227AquaDermSion Brands LLC00322E2020-09-01
00860010195703LaviorLavior Pharma Inc.DWC10US12023-10-16
00860010195734LaviorLavior Pharma Inc.NDWC10US12023-10-23
00850083365011LaviorLavior Pharma Inc.DWG10US12026-07-17
00850083365028LaviorLavior Pharma Inc.MWG10US12026-07-17
06970206820808kegel Hydrogel DressingJiangsu NewValue Medical Products Co.,Ltd.Island2026-06-22
06970206829191PreviClear Border Sacrum Transparent Gel DressingJiangsu NewValue Medical Products Co.,Ltd.Border2026-06-23
06970206829207PreviClear Border Sacrum Transparent Gel DressingJiangsu NewValue Medical Products Co.,Ltd.Border2026-06-23
00324357010155Zeni MedicalFocus Health Group, Inc.10015-AG2026-04-13
00324357100252Zeni MedicalFocus Health Group, Inc.10025252026-04-13
00324357104045Zeni MedicalFocus Health Group, Inc.1000442026-04-13
00860007891168TRAUMAGEL®Cresilon, Inc.TG-00022026-06-01
01714196112452DermaRite Medical Wound Gel- Amorphous HydrogelSion Brands LLC112452026-06-01
00000050223473Intrasite Gel Applipak 8g USA Ctn 10SMITH & NEPHEW MEDICAL LIMITED660273082020-05-15
00000050223480Intrasite Gel Applipak 15g USA Ctn 10SMITH & NEPHEW MEDICAL LIMITED660273112020-05-15
00000050223497Intrasite Gel Applipak 25g USA Ctn 10SMITH & NEPHEW MEDICAL LIMITED660273132020-05-15
00011822089470Rite Aid RITE AID CORPORATION0118220894702021-01-19
00017276234701CARE SCIENCEAso LLC0172762347012019-05-02
00017276234749CARE SCIENCEAso LLC0172762347492020-02-28
00017276234893Up&UpTARGET CORPORATION2450708662020-09-27
00027479251016Spand-Gel MEDI-TECH INTERNATIONAL CORPORATIONSPHFM12019-06-11
00027479251023Spand-GelMEDI-TECH INTERNATIONAL CORPORATIONSPHFM22019-06-11
00027479251030Spand-GelMEDI-TECH INTERNATIONAL CORPORATIONSPHBW12019-06-11
00027479251047Spand-GelMEDI-TECH INTERNATIONAL CORPORATIONSPHNW12019-06-11
00027479251054Spand-GelMEDI-TECH INTERNATIONAL CORPORATIONSPHSA22019-06-11
00027479251061Spand-GelMEDI-TECH INTERNATIONAL CORPORATIONSPHSA32019-06-11
00027479251078Spand-GelMEDI-TECH INTERNATIONAL CORPORATIONSPHSA42019-06-11
00027479251085Spand-GelMEDI-TECH INTERNATIONAL CORPORATIONSPHSA4.52019-06-11
00027479251092Spand-GelMEDI-TECH INTERNATIONAL CORPORATIONSPHSA52019-06-11
00027479251108Spand-Gel MEDI-TECH INTERNATIONAL CORPORATIONSPHSA62019-06-11
00027479251115Spand-GelMEDI-TECH INTERNATIONAL CORPORATIONSPHSA6.92019-06-11
00027479251122Spand-GelMEDI-TECH INTERNATIONAL CORPORATIONSPHSA82019-06-11
00040565115276SOLOSITESMITH & NEPHEW MEDICAL LIMITED4496002023-01-31
00041520089359CareOneAhold U.S.A., Inc.0415200893592019-07-31
00050428447420CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATED3765512020-09-07
00074676134116Mueller Sports MedicineMueller Sports Medicine, Inc.1314112022-08-31
00074676134123Mueller Sports MedicineMueller Sports Medicine, Inc.1314122022-08-31
00074676207247Mueller Blister KitMueller Sports Medicine, Inc.2007242022-08-31
00090205022679EltaMD Laser Enzyme Gel 2ozCP Skin Health Group, Inc.022672022-12-13
00093351031854Discount Drug Mart Food FairDISCOUNT DRUG MART, INC.0933510318542020-09-14
00189116000071Regenacyn Plus Scar Management Hydrogel Sonoma Pharmaceuticals, Inc.848752022-12-02
00189116000750Microcyn Skin & Wound HydroGelSonoma Pharmaceuticals, Inc.847502022-12-01
00189116000804Microcyn Skin & Wound HydroGelSonoma Pharmaceuticals, Inc.848042022-12-01
00197998326882Solventum™ Nu-Gel™Solventum Germany GmbHMNG4152025-09-22
00197998326967Solventum™ Nu-Gel™Solventum Germany GmbHMNG4252025-09-22
00198715994278Advanced Scar & Wound HydrogelSonoma Pharmaceuticals, Inc.860402025-05-07
00303620002097Orasoothe Oral Coating Rinse 4oz – ProfessionalSEPTODONT SAS SPECIALITES SEPTODONT01S06202022-12-19
00303620002103Orasoothe Oral Coating Rinse 4oz – HygieneSEPTODONT SAS SPECIALITES SEPTODONT01S06302022-12-19
00311701161021WOUN'DRESColoplast A/S11662022-04-22
00311701161168WOUN'DRESColoplast A/S76902022-04-22
00311917189574Well At WalgreensWALGREEN CO.9731812020-07-14
00361554005614GentellGentell, LLCGEN-117002025-02-14
00361554005638GentellGentell, LLCGEN-114702025-02-14
00365197409006A+D Antimicrobial Hydrogel SpraySonoma Pharmaceuticals, Inc.860312025-04-04
00365197409204A+D Hydrogel Spray Advanced Dermatitis CareSonoma Pharmaceuticals, Inc.860462025-11-24
00365197409303A+D Antimicrobial Hydrogel SpraySonoma Pharmaceuticals, Inc.860422025-06-10
00365197504008Solarcaine Advanced Burn Relief HydrogelSonoma Pharmaceuticals, Inc.860352025-07-22
00365197504107Solarcaine Advanced Burn Relief HydrogelSonoma Pharmaceuticals, Inc.504102025-09-05
00365197760107Bikini Skin Soothing GelSonoma Pharmaceuticals, Inc.860472025-10-08
00365197851003Bactine Antimicrobial Hydrogel Spray Sonoma Pharmaceuticals, Inc.860452026-01-16