FDA.reportPublic FDA data

General oral wound dressing, animal-derived

Definition
A collagen protein matrix derived from animal products (e.g., porcine, bovine) intended to be used as a protective cover for the general oral mucosa to manage wounds and sores in the mouth such as ulcers (non-infected or viral), periodontal surgical wounds, suture sites, burns, extraction sites, surgical wounds, and traumatic wounds; it may in addition, or alternatively, be intended to treat mucosal irritations/inflammation, dryness, and/or gingivitis. It may be supplied in various forms (e.g., gel, paste, fluid, water/oil spray solution) for use in the home or a clinical setting. After application, this device cannot be reused.
GUDID devices
189
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00614950007219RCP Resorbable Collagen PlugACE SURGICAL SUPPLY CO., INC.50940002015-10-24
00614950007226RCF Resorbable Collagen FoamACE SURGICAL SUPPLY CO., INC.50920002015-10-24
00614950007233RCT Resorbable Collagen TapeACE SURGICAL SUPPLY CO., INC.50910002015-10-24
00614950007592OUSIA bioPLUGACE SURGICAL SUPPLY CO., INC.OUSPG2015-10-24
00614950007608OUSIA bioSTRIPACE SURGICAL SUPPLY CO., INC.OUSTP2015-10-24
00614950007707OUSIA bioKOTEACE SURGICAL SUPPLY CO., INC.OUSKT2015-10-24
00614950007806OUSIA bioPLUGACE SURGICAL SUPPLY CO., INC.OUSPGS2015-10-24
00614950007813OUSIA bioSTRIPACE SURGICAL SUPPLY CO., INC.OUSTPS2015-10-24
00614950007820Collatene Micro Fibrillar CollagenACE SURGICAL SUPPLY CO., INC.50910102015-10-24
00614950008117RCP Resorbable Collagen PlugACE SURGICAL SUPPLY CO., INC.B50940002016-01-18
00614950008148RCT Resorbable Collagen TapeACE SURGICAL SUPPLY CO., INC.T50910002016-01-18
00614950008162RCP Resorbable Collagen PlugACE SURGICAL SUPPLY CO., INC.T50940002016-01-18
00614950008704REGENX PuraPLUGACE SURGICAL SUPPLY CO., INC.PGKTE12016-12-15
00614950008711REGENX PuraTAPEACE SURGICAL SUPPLY CO., INC.PGPLG12016-12-15
00614950008728REGENX PuraKOTEACE SURGICAL SUPPLY CO., INC.PGTPE12016-12-15
00813954022024MatrixDerm TapeCOLLAGEN MATRIX, INC.BDDWDT25752023-03-10
00813954022031MatrixDerm FoamCOLLAGEN MATRIX, INC.BDDWDF20402023-03-10
00813954022048MatrixDerm PlugCOLLAGEN MATRIX, INC.BDDWDP10202023-03-10
00813954022055CollateneCOLLAGEN MATRIX, INC.DWDG00102023-02-02
00813954022079neotapeCOLLAGEN MATRIX, INC.neotape2017-04-21
00813954022086neocoteCOLLAGEN MATRIX, INC.neocote2017-04-21
00813954022093neoplugCOLLAGEN MATRIX, INC.neoplug2017-04-21
00813954026756PuraPLUGCOLLAGEN MATRIX, INC.YSSPLG2025-03-26
00813954026763PuraTAPECOLLAGEN MATRIX, INC.YSSTPE2025-03-26
00813954026770PuraKOTECOLLAGEN MATRIX, INC.YSSKTE2025-03-26
00813954027142PLENA WOUND DRESSING PLUGCOLLAGEN MATRIX, INC.BDDWDP10202025-07-16
00813954027159PLENA WOUND DRESSING TAPECOLLAGEN MATRIX, INC.BDDWDT25752025-07-16
00813954027166PLENA WOUND DRESSING FOAMCOLLAGEN MATRIX, INC.BDDWDF20402025-07-16
00813954027173Collagen TapeCOLLAGEN MATRIX, INC.0100Z2025-07-18
00813954027180Collagen PatchCOLLAGEN MATRIX, INC.0101Z2025-07-18
00813954027197Collagen PlugCOLLAGEN MATRIX, INC.0102Z2025-07-18
00813954027838BioPlugCOLLAGEN MATRIX, INC.BIOPLUG2026-01-06
00813954027845BioStripCOLLAGEN MATRIX, INC.BIOSTRIP2026-01-06
00813954027883RCTCOLLAGEN MATRIX, INC.50910002026-01-06
00813954027890RCFCOLLAGEN MATRIX, INC.50920002026-01-06
00813954027906RCPCOLLAGEN MATRIX, INC.50940002026-01-06
00813954028316Bicon Resorbable Collagen PlugCOLLAGEN MATRIX, INC.260-509-4002026-01-06
00813954028385collateneCOLLAGEN MATRIX, INC.50910102026-05-05
00813954028439Tissue Specialists Resorbable Collagen PlugCOLLAGEN MATRIX, INC.T50940002026-03-09
00813954028446Tissue Specialists Resorbable Collagen TapeCOLLAGEN MATRIX, INC.T50910002026-03-09
00813954028545bioSTRIPCOLLAGEN MATRIX, INC.OUSTPS2026-03-09
00813954028552bioPLUGCOLLAGEN MATRIX, INC.OUSPGS2026-03-09
00813954028569bioKOTECOLLAGEN MATRIX, INC.OUSKTS2026-03-09
00813954028736SALVIN OraCOTE+COLLAGEN MATRIX, INC.ORACOTE-PLUS-PKG-102026-03-18
00813954028743SALVIN OraPLUG+COLLAGEN MATRIX, INC.ORAPLUG-PLUS-PKG-102026-03-18
00813954028750SALVIN OraTAPE+COLLAGEN MATRIX, INC.ORATAPE-PLUS-PKG-102026-03-18
00870053001039HemCon® Dental Dressing PRO, 10mm x 12mmTRICOL BIOMEDICAL, INC.12021-07-09
00870053001114HemCon® Dental Dressing PRO, 1in x 3inTRICOL BIOMEDICAL, INC.12021-07-09
04714691213132Omniplug Collagen Wound DressingMAXIGEN BIOTECH INC.HAD0010202024-07-26
04714691213170Omniplug Collagen Wound DressingMAXIGEN BIOTECH INC. HAD0015202024-07-26
04714691213477HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.HAD0010202024-07-26
04714691213484HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC. HAD0015202024-07-26
04714691213552HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.HADB1010302024-11-18
04714691213569HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.HADB1515302024-11-18
04714691213576HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.HADB1504302024-11-18
04714691213705Guide Plug Collagen Wound Dressing MAXIGEN BIOTECH INC.HAD0010202025-03-13
04714691213712Guide Plug Collagen Wound DressingMAXIGEN BIOTECH INC.HAD0015202025-03-13
04714691213903HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.HADB1010302025-09-30
04714691213910HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.HADB2530302025-09-30
04714691213934VeraFill Dental Collagen Wound DressingMAXIGEN BIOTECH INC.HAD0010202025-11-04
04714691213958VeraFill Dental Collagen Wound DressingMAXIGEN BIOTECH INC.HAD0015202026-03-30
04714691850443Curagen collagen wound dressingMAXIGEN BIOTECH INC.HAD2040302024-11-18
04714691850450Curagen collagen wound dressingMAXIGEN BIOTECH INC.HAD0015202024-11-18
10381780000259CollaPlug®Integra Lifesciences Corporation01022014-09-11
10381780000266CollaCote®Integra Lifesciences Corporation01012014-09-11
10381780000273CollaTape®Integra Lifesciences Corporation01002014-09-11
10381780000280Integra® Miltex® HeliTape®Integra Lifesciences Corporation622002014-09-11
10381780000297Integra® Miltex® HeliTape®Integra Lifesciences Corporation622012014-09-11
10381780000303Integra® Miltex® HeliTape®Integra Lifesciences Corporation622022014-09-11
10381780000327ORAPLUG®Integra Lifesciences Corporation#ORAPLUG-PKG-102014-09-11
10381780490012creos™Integra Lifesciences CorporationWD622002018-09-28
10381780490029creos™Integra Lifesciences CorporationWD622012018-09-28
10381780490036creos™Integra Lifesciences CorporationWD622022018-09-28
10813954021512Zimmer Collagen TapeCOLLAGEN MATRIX, INC.0100Z2016-08-01
10813954021529Zimmer Collagen PatchCOLLAGEN MATRIX, INC.0101Z2016-08-01
10813954021536Zimmer Collagen PlugCOLLAGEN MATRIX, INC.0102Z2016-08-01
10813954023509naturesQue ColAid BCOLLAGEN MATRIX, INC.584992020-02-25
10813954023561MaxxPlugCOLLAGEN MATRIX, INC.XPLUG2020-06-02
10813954023578MaxxTapeCOLLAGEN MATRIX, INC.XTAPE2020-06-02
10813954023585MaxxCoteCOLLAGEN MATRIX, INC.XCOTE2020-06-02