FDA.reportPublic FDA data

Halyard

Primary DI
10885632434303
Brand
Halyard
Company
OWENS & MINOR DISTRIBUTION, INC.
Model
56352
Device description
HALYARD Collagen particles, 1g
Published
2026-05-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KGNWound Dressing With Animal-Derived Material(S)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGNWound Dressing With Animal-Derived Material(S)UnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20885632434300PackageGS1400In Commercial Distribution
30885632434307PackageGS110In Commercial Distribution
10885632434303PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088563243430020885632434300
3088563243430730885632434307
1088563243430310885632434303

GMDN Terms#

Term, Definition table
TermDefinition
Animal-derived wound matrix dressingA bioabsorbable animal-derived protein matrix [e.g., peptides derived from collagen] designed to provide: 1) a matrix of structural proteins and/or 2) a skin template of living cells [fibroblasts], to facilitate the infiltration/attachment of native cells/tissues (e.g., blood vessels) for wound/skin healing. It is available in various forms [e.g., solution, powder, occlusive/semi-occlusive cover (non-oral)] and may include additional compounds (e.g., alginate, fatty acids). It may be intended to be covered with a secondary dressing. It is commonly intended for treating partial- and full-thickness wounds, ulcers, and draining, surgical, and traumatic wounds. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Regulatory Flags#

DUNS number
007941230
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885632522079SurgiTrackSM450045D71A2026-05-28
10885632434266Halyard563482026-05-22
10885632468490Halyard614862026-05-22
10885632468506Halyard614872026-05-22
10885632468513Halyard614882026-05-22
10885632468520Halyard614892026-05-22
10885632509032Halyard620732026-05-22
10885632509049Halyard620742026-05-22
10885632509056Halyard620752026-05-22
10885632509063Halyard620762026-05-22
10885632510199Halyard620772026-05-22
10885632521751SurgiTrackSM450130D17D2026-05-22
10885632521607SurgiTrackSM4500452F842026-05-19
10885632521638SurgiTrackSM45007841332026-05-19
10885632521522SurgiTrackSM4500410A672026-05-18
10885632521577SurgiTrackSM450041BC2C2026-05-18
10885632521584SurgiTrackSM45004117402026-05-18
10885632521591SurgiTrackSM45004113802026-05-18
10885632521317SurgiTrackSM450178CA972026-05-13
10885632434228Halyard563442026-05-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00813954028385collateneCOLLAGEN MATRIX, INC.KGN2026-05-05
10840330705858ProCureTwin Med, LLCKGN2026-05-04
10840330705834ProCureTwin Med, LLCKGN2026-04-28
10840330705841ProCureTwin Med, LLCKGN2026-04-28
00812593023119NeoForm AWCBiogennix, LLCKGN2026-04-27
00812593023126NeoForm AWCBiogennix, LLCKGN2026-04-27
00812593023072NeoSurg Surgical CollagenBiogennix, LLCKGN2026-04-22
00812593023089ossFX Surgical CollagenBiogennix, LLCKGN2026-04-22
00812593023096ossFX Surgical CollagenBiogennix, LLCKGN2026-04-22
00812593023102ColSyntekBiogennix, LLCKGN2026-04-22
10885632434280HalyardOWENS & MINOR DISTRIBUTION, INC.KGN2026-04-16
10885632434297HalyardOWENS & MINOR DISTRIBUTION, INC.KGN2026-04-16
00324357900012Zeni MedicalFocus Health Group, Inc.KGN2026-04-13
00324357900777Zeni MedicalFocus Health Group, Inc.KGN2026-04-13
00812593023058Agilon Surgical Collagen +Biogennix, LLCKGN2026-04-02
00812593023065Agilon Surgical Collagen +Biogennix, LLCKGN2026-04-02
00812593023034CuraSurg Surgical CollagenBiogennix, LLCKGN2026-04-01
00812593023041CuraSurg Surgical CollagenBiogennix, LLCKGN2026-04-01
10885632434273HalyardOWENS & MINOR DISTRIBUTION, INC.KGN2026-03-31
16942327004853DimoraWinner Medical Co., Ltd.KGN2026-03-30
16942327019628DimoraWinner Medical Co., Ltd.KGN2026-03-30
16942327050027DimoraWinner Medical Co., Ltd.KGN2026-03-30
00813954028736SALVIN OraCOTE+COLLAGEN MATRIX, INC.KGN2026-03-18
00813954028743SALVIN OraPLUG+COLLAGEN MATRIX, INC.KGN2026-03-18
00813954028750SALVIN OraTAPE+COLLAGEN MATRIX, INC.KGN2026-03-18
10888277720725MEDLINEMEDLINE INDUSTRIES, INC.KGN2026-03-10
10888277720732MEDLINEMEDLINE INDUSTRIES, INC.KGN2026-03-10
00813954028439Tissue Specialists Resorbable Collagen PlugCOLLAGEN MATRIX, INC.KGN2026-03-09
00813954028446Tissue Specialists Resorbable Collagen TapeCOLLAGEN MATRIX, INC.KGN2026-03-09
00813954028545bioSTRIPCOLLAGEN MATRIX, INC.KGN2026-03-09