FDA.reportPublic FDA data

Hyalomatrix

Primary DI
00817337000616
Brand
Hyalomatrix
Company
Anika Therapeutics, Inc.
Model
6000232
Device description
Hyalomatrix 2.5 cm x 2.5 cm
Published
2026-02-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
QSZAbsorbable Synthetic Wound Dressing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QSZAbsorbable Synthetic Wound DressingUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K073251000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K073251000HYALOMATRIX PAFidia Advanced Biopolymers Srl2007-12-14QSZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817337000616PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817337000616008173370006168173370006160817337000616

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic wound matrix dressingA sterile bioabsorbable device designed to be applied to hard-to-heal wounds (e.g., diabetic and venous insufficiency ulcers) or burns that involve the dermis, and that provides a matrix of structural synthetic fibres to facilitate the infiltration of native skin elements (e.g., fibroblasts, leukocytes, blood vessels) for skin regeneration; it may in addition be intended to facilitate regeneration of hard tissues such as bone (e.g., in cases of osteomyelitis) and may provide wound exudate absorbency. It does not contain biological materials. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
807613393
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817337000050SCS 17-0160000412019-07-22
00817337000074Tactoset60000412019-10-15
00817337000586Integrity Retractable Implant Inserter60001272026-10-05
M06760001200Integrity Delivery Instrument, Tissue Tack60001202023-11-14
00817337000364NanoFx FURS-41012026-05-21
00817337000418Integrity Implant60001132026-01-05
00817337000425Integrity Implant60001142025-09-19
00866142000007Hydrelle685-0152014-09-30
08033549790738Epifilm Otologic653-20014170002018-02-19
08033549790745Epidisc 2pk Otologic 8mm653-30014171002018-02-19
08033549790752EpiDisc TM Perf Patch Kit653-16014171512018-02-19
08033549790769Merogel Injectable640-023CFN 15180002016-09-24
08033549790974Epifilm Otologic653-20014170002018-11-08
08033549790981Epidisc 2pk Otologic 8mm653-30014171002018-11-08
08033549790998EpiDisc TM Perf Patch Kit653-16014171512018-11-08
08033549791117MEROGEL 2pk 4x4cm65114115170022024-04-18
08033549791124MEROGEL 1PK 4x4cm65114015170002024-04-18
08033549791063Epifilm Otologic653-20014170002022-02-04
08033549790714Merogel Nasal Dressing/Sinus Stent &Otologic Packing 2pk 4x4cm651-14115170022018-02-19
08033549790721Merogel Nasal Dressing/Sinus Stent &Otologic Packing 4x4cm651-14015170002018-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06977727072655Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.QSZ2026-10-08
06977727072662Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.QSZ2026-10-08
06977727072679Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.QSZ2026-10-08
06977727072686Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.QSZ2026-10-08
06977727072853SurCura Wound MatrixBeijing Kreate Medical Co., Ltd.QSZ2026-10-08
06977727072860SurCura Wound MatrixBeijing Kreate Medical Co., Ltd.QSZ2026-10-08
06977727072877SurCura Wound MatrixBeijing Kreate Medical Co., Ltd.QSZ2026-10-08
06977727072884SurCura Wound MatrixBeijing Kreate Medical Co., Ltd.QSZ2026-10-08
09349155003865NovoSorb SynPathPOLYNOVO BIOMATERIALS PTY LIMITEDQSZ2026-06-25
09349155003988NovoSorb SynPathPOLYNOVO BIOMATERIALS PTY LIMITEDQSZ2026-06-25
09349155004169NovoSorb SynPathPOLYNOVO BIOMATERIALS PTY LIMITEDQSZ2026-06-25
09349155004404NovoSorb SynPathPOLYNOVO BIOMATERIALS PTY LIMITEDQSZ2026-06-25
06977727072617Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.QSZ2026-04-30
06977727072624Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.QSZ2026-04-30
06977727072631Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.QSZ2026-04-30
06977727072648Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.QSZ2026-04-30
06977727072815SurCura Wound MatrixBeijing Kreate Medical Co., Ltd.QSZ2026-04-30
06977727072822SurCura Wound MatrixBeijing Kreate Medical Co., Ltd.QSZ2026-04-30
06977727072839SurCura Wound MatrixBeijing Kreate Medical Co., Ltd.QSZ2026-04-30
06977727072846SurCura Wound MatrixBeijing Kreate Medical Co., Ltd.QSZ2026-04-30
00854258006389Restrata(R)Acera Surgical IncQSZ2026-04-15
00854258006396Restrata MeshedAcera Surgical IncQSZ2026-04-15
00850021883072SiOxD® ORSioxmed, LLCQSZ2026-03-17
00812005030537Mirragen Advanced Wound MatrixETS Wound Care LLCQSZ2026-03-03
00850021883003SiOxD Wound MatrixSioxmed, LLCQSZ2025-11-10
00850021883041SiOxD Wound MatrixSioxmed, LLCQSZ2025-11-10
00850047730305Foundation DRS SoloBionova Medical Inc.QSZ2025-09-17
00850047730312Foundation DRS SoloBionova Medical Inc.QSZ2025-09-17
00850047730329Foundation DRS SoloBionova Medical Inc.QSZ2025-09-17
00850047730336Foundation DRS SoloBionova Medical Inc.QSZ2025-09-17