FDA.reportPublic FDA data

Halyard

Primary DI
10809160538999
Brand
Halyard
Company
MEDICAL ACTION INDUSTRIES INC.
Model
LLOF006-01
Published
2026-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
PUIDrape, surgical, exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUIDrape, Surgical, ExemptGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10809160538999PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1080916053899910809160538999

GMDN Terms#

Term, Definition table
TermDefinition
Surgical towelA sterile cloth used in the operating room (OR) to absorb extraneous fluids. 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
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
10809160540626HalyardLLOF2700-022026-10-14
10809160540473Medical Action IndustriesLH_851772026-10-12
10809160540480HalyardSHAN454-052026-10-12
10809160540107Medical Action IndustriesLMHA01-012026-10-08
10809160183472Medical Action Industries773452018-03-22
10809160536803HalyardHVMC003-042026-09-18
10809160539965Medical Action Industries845252026-10-06
10809160539125HalyardLLOF021-012026-09-30
10809160539019Medical Action Industries83989B2026-09-25
10809160539026HalyardDNAZ037-032026-09-25
10809160535523HalyardLLOF3100-022026-09-24
10809160538913HalyardMHSH2002-012026-09-24
10809160538937HalyardAXOG2000-122026-09-24
10809160538968HalyardDNAZ034-032026-09-24
10809160536889HalyardMEPK70E-012026-09-22
10809160538579HalyardVMED013-062026-09-22
10809160538609HalyardLH_267001_B12026-09-22
10809160538326HalyardSLNC22-022026-09-21
10809160538333HalyardBHPK801-012026-09-21
10809160538340HalyardASLH9728-012026-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850067913085SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913092SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913108SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913115SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913122SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913139SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913146SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913153SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913160SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913191SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913214SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913221SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00748426264575Medline-MicrotekMicrotek Medical LLCPUI2026-10-14
10192253072211CONVERTORSCardinal Health 200, LLCPUI2026-10-14
10192253072228CONVERTORSCardinal Health 200, LLCPUI2026-10-14
10192253072235CONVERTORSCardinal Health 200, LLCPUI2026-10-14
10192253072242CONVERTORSCardinal Health 200, LLCPUI2026-10-14
10192253072259CONVERTORSCardinal Health 200, LLCPUI2026-10-14
20193489029946MedlineMEDLINE INDUSTRIES, INC.PUI2026-10-14
20748426264531Medline-MicrotekMicrotek Medical LLCPUI2026-10-14
20748426264593Medline-MicrotekMicrotek Medical LLCPUI2026-10-14
20748426264623Medline-MicrotekMicrotek Medical LLCPUI2026-10-14
20888277636597MedlineMEDLINE INDUSTRIES, INC.PUI2026-10-14
20888277636627MedlineMEDLINE INDUSTRIES, INC.PUI2026-10-14
00748426264605Medline-MicrotekMicrotek Medical LLCPUI2026-10-13
00748426264636Medline-MicrotekMicrotek Medical LLCPUI2026-10-13
07467423230682Smith and NephewDAS Medical International SRLPUI2026-10-13
00748426264568Medline-MicrotekMicrotek Medical LLCPUI2026-10-12
16931918199627AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-09-29
10850091824002AeroKEEHealkee Medical USA Inc.PUI2026-09-24