FDA.reportPublic FDA data

HALYARD

Primary DI
10809160541739
Brand
HALYARD
Company
MEDICAL ACTION INDUSTRIES INC.
Model
LLOG020-04
Published
2026-10-26
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
KDDKit, surgical instrument, disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDDKit, Surgical Instrument, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160541736PackageGS110In Commercial Distribution
10809160541739PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916054173620809160541736
1080916054173910809160541739

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00
Special Storage Condition, Specify00STORE AT ROOM TEMPERATURE

Regulatory Flags#

DUNS number
092364462
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
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
10809160541531HalyardGTMO0072026-10-26
10809160541722HalyardDADC008-032026-10-26
10809160541746HalyardONEL1165-042026-10-26
10809160541753HalyardONEL1170-052026-10-26
10809160541760HalyardAV010908-152026-10-26
10809160541470HalyardLCOD004-012026-10-23
10809160541487HalyardDADC009-032026-10-23
10809160541494HalyardONEL1180-052026-10-23
10809160541500HALYARDMETC002-012026-10-23
10809160541517HALYARDWBAM068-032026-10-23
10809160541524HALYARDVMED013-032026-10-23
10809160538913HalyardMHSH2002-012026-09-24
10809160541029Medical Action IndustriesDNAG082026-10-21
10809160541036Medical Action IndustriesDNPP092026-10-21
10809160541043Medical Action IndustriesDNSP112026-10-21
10809160541050Medical Action IndustriesDNUR812026-10-21
10809160541067Medical Action IndustriesDNVP972026-10-21
10809160540879MEDICAL ACTION INDUSTRIES79143C2026-10-20
10809160540626HalyardLLOF2700-022026-10-14
10809160540473Medical Action IndustriesLH_851772026-10-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850074437208OftalOnePackOFTAL-ONE INC.KDD2026-10-21
00749756400442DeRoyalDEROYAL INDUSTRIES, INC.KDD2026-09-21
00749756394666DeRoyalDEROYAL INDUSTRIES, INC.KDD2026-09-18
00749756397193DeRoyalDEROYAL INDUSTRIES, INC.KDD2026-09-18
00749756401708DeRoyalDEROYAL INDUSTRIES, INC.KDD2026-09-18
00749756401715DeRoyalDEROYAL INDUSTRIES, INC.KDD2026-09-18
00889795154668Primal OCDParagon 28, Inc.KDD2026-07-14
00889795154675Primal OCDParagon 28, Inc.KDD2026-07-14
00889795154682Primal OCDParagon 28, Inc.KDD2026-07-14
20653405990328Infinity™Conmed CorporationKDD2026-06-10
08800071700500TIGER GUARD PLUSKims Med Co.,Ltd.KDD2025-11-28
10080196042777MEDLINEMEDLINE INDUSTRIES, INC.KDD2025-06-02
B562PKGS000100Micro Surgery KitWishbone Medical, Inc.KDD2024-12-30
B562PKGS000200Minor Surgery KitWishbone Medical, Inc.KDD2024-12-30
08800071700166Tiger GuardKims Med Co.,Ltd.KDD2024-10-21
08800071700111Tiger GuardKims Med Co.,Ltd.KDD2024-07-30
10193489951936Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2024-07-29
08906039319729OSSEOUS Myringotomy Kit-StandardEON MEDITECH PRIVATE LIMITEDKDD2024-07-04
08906039319736OSSEOUS Myringotomy Kit-Pediatric EON MEDITECH PRIVATE LIMITEDKDD2024-07-04
10192253065442Aero-MedAERO-MED, LLCKDD2024-03-11
00811870037979Manus Medical, LLCManus Medical, LLCKDD2024-02-06
10195327271626Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10195327271770Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10193489447897Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-08
10195327264192Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-08
10195327265762Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-08
10195327266646Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-08
10195327266271Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-03-05
08800071700050EZ Fan Funnel 2KimsMed Co.,Ltd.KDD2023-02-06
10195327271633Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2022-12-18