FDA.reportPublic FDA data

microMend PRO

Primary DI
00850018777216
Brand
microMend PRO
Company
Kitotech Medical Inc
Model
MM01XS2
Catalog number
MM01XS2
Device description
Skin Closure Devices: Small - 7 mm x 28 mm (2 Closures per Pouch)
Published
2022-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDTStaple, Removable (Skin)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDTStaple, Removable (Skin)General, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850018777339PrimaryGS10
00850018777216Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850018777339008500187773398500187773390850018777339
00850018777216008500187772168500187772160850018777216

GMDN Terms#

Term, Definition table
TermDefinition
Skin-closure adhesive stripA small, narrow flexible band (of fabric, plastic, paper, or other material) coated on one side with a pressure-sensitive adhesive, used to approximate the edges of superficial wounds. The device may be hypoallergenic and/or waterproof. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature16 Degrees Celsius26 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(877) 420-1502customerservice@kitotechmedical.com

Regulatory Flags#

DUNS number
007908602
Device count
2
DM exempt
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850018777087microMend PROMM12SM2MM12SM22022-12-08
00850018777100microMend PROMM12LG2MM12LG22022-12-08
00850018777124microMend PROMM12SM4MM12SM42022-12-08
00850018777162microMend PROMM12W2SMM12W2S2022-12-08
00850018777186microMend PROMM12W2AMM12W2A2022-12-08
00850018777285microMend PROMM12LG4MM12LG42022-12-08
00850018777308microMend PROMM12SU2MM12SU22022-12-08
00850018777315microMend PROMM01SU2MM01SU22022-12-08
00850018777322microMend PROMM01SM2MM01SM22022-12-08
00850018777339microMend PROMM01XS2MM01XS22022-12-08
00850018777346microMend PROMM01LG2MM01LG22022-12-08
00850018777360microMend PROMM01W2SMM01W2S2022-12-08
00850018777391microMend PROMM01W2AMM01W2A2022-12-08
00850018777469BackViveP2B1D001P2B1D0012024-04-26
00850018777025microMendM3S2D001M3S2D0012022-12-08
00850018777049microMend PROMM12XS2MM12XS22022-12-08
00850018777117microMend PROMM12SM4MM12SM42022-12-08
00850018777223microMendM2SXD002M2SXD0022022-12-08
00850018777261microMend MSXWD004MSXWD0042022-12-08
00850018777278microMend PROMM12LG4MM12LG42022-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00661392055148LSL HEALTHCARELSL Industries, LLCGDT2025-10-30
10197344111053MEDLINEMEDLINE INDUSTRIES, INC.GDT2025-03-05
20197344111050MEDLINEMEDLINE INDUSTRIES, INC.GDT2025-03-05
10080196846924Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GDT2025-02-16
40080196846925Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GDT2025-02-16
00192896120228Michel Wound ClipsSONTEC INSTRUMENTS, INC.GDT2024-10-15
14026704741943WECKTELEFLEX INCORPORATEDGDT2024-07-17
24026704741940WECKTELEFLEX INCORPORATEDGDT2024-07-17
04717480900374Taiwan SurgicalTAIWAN SURGICAL CORPORATIONGDT2023-08-02
04719880180493Haritex CorporationHARITEX CORPORATIONGDT2023-06-19
10841767102944Trinity Sterile, Inc.Trinity Sterile, Inc.GDT2023-03-09
00841767102947Trinity Sterile, Inc.Trinity Sterile, Inc.GDT2023-03-09
00850018777087microMend PROKitotech Medical IncGDT2022-12-08
00850018777100microMend PROKitotech Medical IncGDT2022-12-08
00850018777124microMend PROKitotech Medical IncGDT2022-12-08
00850018777162microMend PROKitotech Medical IncGDT2022-12-08
00850018777186microMend PROKitotech Medical IncGDT2022-12-08
00850018777285microMend PROKitotech Medical IncGDT2022-12-08
00850018777308microMend PROKitotech Medical IncGDT2022-12-08
00850018777315microMend PROKitotech Medical IncGDT2022-12-08
00850018777322microMend PROKitotech Medical IncGDT2022-12-08
00850018777339microMend PROKitotech Medical IncGDT2022-12-08
00850018777346microMend PROKitotech Medical IncGDT2022-12-08
00850018777360microMend PROKitotech Medical IncGDT2022-12-08
00850018777391microMend PROKitotech Medical IncGDT2022-12-08
00850018777025microMendKitotech Medical IncGDT2022-12-08
00850018777049microMend PROKitotech Medical IncGDT2022-12-08
00850018777117microMend PROKitotech Medical IncGDT2022-12-08
00850018777223microMendKitotech Medical IncGDT2022-12-08
00850018777261microMend Kitotech Medical IncGDT2022-12-08