FDA.reportPublic FDA data

Perilav

Primary DI
B674WIKB2001101
Brand
Perilav
Company
Stiehl Tech, LLC
Model
Body 20” with 12” x 12” Treatment Hole
Catalog number
WIKB2001
Device description
Wound irrigation kit containing 20” Body with 12” x 12” Treatment Hole Fluid Collection Bag, with separately packed chlorhexidine prep wipes, solidifier, and twist tie.
Published
2026-05-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FONBag, Drainage, With Adhesive, Ostomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FONBag, Drainage, With Adhesive, OstomyGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B674WIKB2001101PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Wound irrigation kitA collection of noninvasive devices intended to be used by a healthcare professional to irrigate/cleanse an acute, chronic, or surgical wound. It consists of multiple items which typically include an irrigation instrument (e.g., syringe, bulb), wipes, towel, drape and/or irrigation solution. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
844-737-4528info@stiehltech.com

Regulatory Flags#

DUNS number
081177942
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B674PL30010PerilavPumpPL30012026-05-13
B674T93LF10PerilavTube SetT93LF52026-05-13
B674WIKB1401101PerilavBody 14” with 3” x 4” Treatment HoleWIKB14012026-05-13
B674WIKB1402101PerilavBody 14” with 5” x 6” Treatment HoleWIKB14022026-05-13
B674WIKE1401101PerilavExtremity 14”WIKE14012026-05-13
B674WIKE2001101PerilavExtremity 20”WIKE20012026-05-13
B674PS022Perilav Pulsatile IrrigatorPS022PS0222020-07-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B674WIKB1401101PerilavStiehl Tech, LLCFON2026-05-13
B674WIKB1402101PerilavStiehl Tech, LLCFON2026-05-13
B674WIKE1401101PerilavStiehl Tech, LLCFON2026-05-13
B674WIKE2001101PerilavStiehl Tech, LLCFON2026-05-13
00768455126798EakinT.G. EAKIN LIMITEDFON2023-05-16
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00768455126828EakinT.G. EAKIN LIMITEDFON2023-05-16
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00768455126842EakinT.G. EAKIN LIMITEDFON2023-05-16
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00768455126866EakinT.G. EAKIN LIMITEDFON2023-05-16
00768455126873EakinT.G. EAKIN LIMITEDFON2023-05-16
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00768455126927EakinT.G. EAKIN LIMITEDFON2023-05-16
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16937359412370SteawoceWuhan Sitaili Medical Apparatus Development Co., Ltd.FON2022-12-15
16937359412356SteadliveWuhan Sitaili Medical Apparatus Development Co., Ltd.FON2022-12-07
00768455105670NATURACONVATEC, PURCHASING DEPARTMENTFON2022-09-29
00768455111916ESTEEM+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29
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00768455113330NATURA+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29
00768455114818ESTEEM SYNERGY+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29
00768455114825ESTEEM SYNERGY+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29