FDA.report

Halyard

Primary DI
10809160304792
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
AVID365_0002
Catalog number
AVID365
Published
2020-12-10
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

Related Records

Product Codes

CodeName
PUIDrape, surgical, exempt

Product Code Classifications

CodeDeviceSpecialtyClass
PUIDrape, Surgical, ExemptGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10809160304792PrimaryGS10

GMDN Terms

TermDefinition
Patient surgical drape, single-use, non-sterileA non-sterile, noninvasive flat sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to isolate a specific anatomical site (e.g., site of surgical incision) from potential contamination (e.g., microbial, substance). The device may also be used to protect a patient from heat/flame during a surgical procedure, however it is not designed with specific heat-reflective or laser resistant materials. This is a single-use device intended to be sterilized prior to use.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(888) 564-7153PIQ@owens-minor.com

Regulatory Flags

DUNS number
015623119
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
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 DIBrandModelCatalogPublished
20809160517236HalyardDRRD48-02_0004DRRD48-022026-03-24
20809160517243HalyardAVMD050-01_0007AVMD050-012026-03-24
20809160517250HalyardUSAR017-12_0006USAR017-122026-03-24
20809160517090HalyardLIFE0240_0006LIFE02402026-03-23
20809160517120HalyardKAFB027_0010KAFB0272026-03-23
20809160517137HalyardUFCF010-03_0008UFCF010-032026-03-23
20809160517144HalyardVMCD018-11_0004VMCD018-112026-03-23
20809160517151HalyardVAML019-09_0004VAML019-092026-03-23
20809160517168HalyardNHJV7000-20_0008NHJV7000-202026-03-23
20809160517175HalyardEAMC109-06_0008EAMC109-062026-03-23
20809160517182HalyardOSTK19-01_0007OSTK19-012026-03-23
20809160517199HalyardDUAC16-01_0010DUAC16-012026-03-23
20809160517205HalyardVAML058_0017VAML0582026-03-23
20809160517212HalyardSAMT100-12_0007SAMT100-122026-03-23
20809160517229HalyardESED52-01_0013ESED52-012026-03-23
20809160516734HalyardLIFE0156-03_0008LIFE0156-032026-03-20
20809160516741HalyardWERP43-01_0002WERP43-012026-03-20
20809160516758HalyardWEGL20-01_0004WEGL20-012026-03-20
20809160516765HalyardWEHY18-01_0002WEHY18-012026-03-20
20809160516772HalyardWEGB22-01_0002WEGB22-012026-03-20

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00849296004916Welmed, Inc.WELMED INC.PUI2026-03-20
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20748426264494Medline-MicrotekMicrotek Medical LLCPUI2026-03-16
10748426264503Medline-MicrotekMicrotek Medical LLCPUI2026-03-16
00634916019353Standard SupremeSTANDARD TEXTILE CO., INC.PUI2026-03-11
00634916120905Instrument HolderSTANDARD TEXTILE CO., INC.PUI2026-03-11
00634916781373WrapPel Table CoverSTANDARD TEXTILE CO., INC.PUI2026-03-11
00634916870633Instrument DrapeSTANDARD TEXTILE CO., INC.PUI2026-03-11
00634916881202Circumcision Drape,STANDARD TEXTILE CO., INC.PUI2026-03-11
00634916881226Split DrapeSTANDARD TEXTILE CO., INC.PUI2026-03-11
00634916881233T-Lap Fenestrated DrapeSTANDARD TEXTILE CO., INC.PUI2026-03-11
04052199810164Foliodrape Protect PlusPAUL HARTMANN AGPUI2026-03-09
04052199810188Foliodrape Protect PlusPAUL HARTMANN AGPUI2026-03-09
04052199810201Foliodrape Protect PlusPAUL HARTMANN AGPUI2026-03-09
04255575119459Sterile Cover KitRaguse Gesellschaft für medizinische Produkte mbHPUI2026-03-03
50198956294569CARDINAL HEALTHCardinal Health 200, LLCPUI2026-03-02
10748426261540NAMicrotek Medical LLCPUI2026-02-26
20197344179487MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-02-23
10197344179497MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-02-23
10748426144577Medline-MicrotekMicrotek Medical LLCPUI2026-02-18
10748426144638Medline-MicrotekMicrotek Medical LLCPUI2026-02-18
10748426144645Medline-MicrotekMicrotek Medical LLCPUI2026-02-18
10748426144690Medline-MicrotekMicrotek Medical LLCPUI2026-02-18
10748426144737Medline-MicrotekMicrotek Medical LLCPUI2026-02-18
10748426144744Medline-MicrotekMicrotek Medical LLCPUI2026-02-18
10748426144751Medline-MicrotekMicrotek Medical LLCPUI2026-02-18
10748426145468Medline-MicrotekMicrotek Medical LLCPUI2026-02-18
10748426145475Medline-MicrotekMicrotek Medical LLCPUI2026-02-18
10748426145505Medline-MicrotekMicrotek Medical LLCPUI2026-02-18
10748426145512Medline-MicrotekMicrotek Medical LLCPUI2026-02-18