FDA.reportPublic FDA data

Perilav

Primary DI
B674WIKE1401101
Brand
Perilav
Company
Stiehl Tech, LLC
Model
Extremity 14”
Catalog number
WIKE1401
Device description
Wound irrigation kit containing 14” Extremity 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
B674WIKE1401101PrimaryHIBCC0

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
B674WIKB2001101PerilavBody 20” with 12” x 12” Treatment HoleWIKB20012026-05-13
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
B674WIKB2001101PerilavStiehl Tech, LLCFON2026-05-13
B674WIKE2001101PerilavStiehl Tech, LLCFON2026-05-13
00768455126798EakinT.G. EAKIN LIMITEDFON2023-05-16
00768455126804EakinT.G. EAKIN LIMITEDFON2023-05-16
00768455126811EakinT.G. EAKIN LIMITEDFON2023-05-16
00768455126828EakinT.G. EAKIN LIMITEDFON2023-05-16
00768455126835EakinT.G. EAKIN LIMITEDFON2023-05-16
00768455126842EakinT.G. EAKIN LIMITEDFON2023-05-16
00768455126859EakinT.G. EAKIN LIMITEDFON2023-05-16
00768455126866EakinT.G. EAKIN LIMITEDFON2023-05-16
00768455126873EakinT.G. EAKIN LIMITEDFON2023-05-16
00768455126880EakinT.G. EAKIN LIMITEDFON2023-05-16
00768455126897EakinT.G. EAKIN LIMITEDFON2023-05-16
00768455126903EakinT.G. EAKIN LIMITEDFON2023-05-16
00768455126910EakinT.G. EAKIN LIMITEDFON2023-05-16
00768455126927EakinT.G. EAKIN LIMITEDFON2023-05-16
16937359412394MaidwocWuhan Sitaili Medical Apparatus Development Co., Ltd.FON2023-04-19
16937359412387Steawoce Wuhan Sitaili Medical Apparatus Development Co., Ltd.FON2022-12-21
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
00768455111985ESTEEM+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29
00768455111992ESTEEM+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29
00768455112036ESTEEM+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29
00768455113330NATURA+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29
00768455114818ESTEEM SYNERGY+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29
00768455114825ESTEEM SYNERGY+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29