FDA.reportPublic FDA data

Halyard

Primary DI
10885632417146
Brand
Halyard
Company
OWENS & MINOR DISTRIBUTION, INC.
Model
55572
Device description
PRIMARY DRESSING SECONDARY WOUND CARE STERILE RECTANGLE SILICONE BEIGE MULTILAYER CA/100 Not made with Natural Rubber Latex Halyard
Published
2026-10-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NADDressing, wound, occlusive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20885632417143PackageGS110In Commercial Distribution
30885632417140PackageGS110In Commercial Distribution
10885632417146PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088563241714320885632417143
3088563241714030885632417140
1088563241714610885632417146

GMDN Terms#

Term, Definition table
TermDefinition
Wound-nonadherent dressing, absorbent, non-antimicrobialA wound covering typically in the form of a multi-layered pad having a material or substance on its skin-contact surface (e.g., silicone gel), or designed to be soaked in saline prior to application, to prevent adherence to the wound bed thereby decreasing wound trauma potential; it does not contain an antimicrobial agent. It is typically used to absorb wound blood/exudates while protecting the wound from external contamination and maintaining a moist internal environment. It may be used as a primary or secondary dressing to treat chronic and postoperative wounds, burns, ulcers, abrasions, cuts, or puncture sites; it is not a dedicated burn dressing. This is a single-use device.

Regulatory Flags#

DUNS number
007941230
Device count
1
DM exempt
false
Premarket exempt
true
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
10885632541131SurgiTrackSM45005945612026-10-22
10885632417122Halyard555702026-10-21
10885632520327HALYARDABC10102026-10-21
10885632520334HALYARDABC10122026-10-21
20885632532129HALYARDABCP10062026-10-21
10885632540776SurgiTrackSM450387ABDC2026-10-19
10885632540844SurgiTrackSM45016406752026-10-19
10885632540851SurgiTrackSM450164E9E92026-10-19
10885632540639SurgiTrackSM450030A8C42026-10-15
10885632540646SurgiTrackSM450030D0722026-10-15
10885632540615SurgiTrackSM450087ABBD2026-10-13
10885632540059SurgiTrackSM4503872A3B2026-10-07
10885632539206SurgiTrackSM450041D1852026-09-29
10885632539039SurgiTrackSM450087473B2026-09-25
10885632538902SurgiTrackSM450048BAEE2026-09-24
10885632537066SurgiTrackSM4501483A7F2026-09-18
10885632537110SurgiTrackSM450070CC682026-09-18
10885632532665SurgiTrackSM450087F5342026-09-04
10885632532726SurgiTrackSM450041DB622026-09-04
10885632531781SurgiTrackSM450071D8E02026-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885632417122HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-10-21
M689HVPIK060H-Vent Vented Chest SealSafeguard US Operating, LLCNAD2026-10-13
00096295146639LEADERCardinal Health 110, Inc.NAD2026-10-09
08806109104180Madeca Medi Patch SpecialDongkook Pharmaceutical Co.,Ltd.NAD2026-09-30
08806109193573MADECA MEDI PATCH FREE-CUT PATCHDongkook Pharmaceutical Co.,Ltd.NAD2026-09-30
08806109193580MADECA MEDI PATCH FREE-CUT PATCHDongkook Pharmaceutical Co.,Ltd.NAD2026-09-30
00749756399258DeRoyalDEROYAL INDUSTRIES, INC.NAD2026-09-21
07333350341596Mepitel®Mölnlycke Health Care ABNAD2026-09-21
05701780265058Biatain AdhesiveColoplast A/SNAD2026-08-27
04719873697779NACARILEX MEDICAL, INC.NAD2026-08-26
04719873697786NACARILEX MEDICAL, INC.NAD2026-08-26
04719873697793NACARILEX MEDICAL, INC.NAD2026-08-26
04719873697809NACARILEX MEDICAL, INC.NAD2026-08-26
04719873697816NACARILEX MEDICAL, INC.NAD2026-08-26
04719873697823NACARILEX MEDICAL, INC.NAD2026-08-26
00850088144925CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-08-14
040640351931573M™ Tegaderm™3M Deutschland GmbHNAD2026-07-24
040640351931953M™ Tegaderm™3M Deutschland GmbHNAD2026-07-24
040640351932323M™ Tegaderm™3M Deutschland GmbHNAD2026-07-24
05060483573083Russell Chest Seal - Twin (US Version)SAFEGUARD MEDICAL TECHNOLOGIES LIMITEDNAD2026-07-24
05060483570006Russell Chest Seal (US Version)SAFEGUARD MEDICAL TECHNOLOGIES LIMITEDNAD2026-07-20
00850088144642CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-10
00850088144659CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-10
00850088144697CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-10
00850088144215CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-08
00850088144222CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-08
00850088144239CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-08
00850088144246CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-08
00850088144253CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-08
00850088144000CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-03