FDA.reportPublic FDA data

DermaQuik

Primary DI
00853909006358
Brand
DermaQuik
Company
Dermaclip Us, L.L.C.
Model
Home & Field Wound Closure Kit
Catalog number
62551
Device description
"DermaQuik Home & Field Wound Closure Kit, OTC. Waterproof kit includes 2 Packages of DermaQuik Home & Field Devices (1 Clip per Package, 1"" Closure per Package), Standard Adhesive. Kit also includes 2 gauze pads, 2 alcohol swabs, 2 wound dressings. All products are packaged individually within the kit and are sterile."
Published
2023-04-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853909006488PackageGS136In Commercial Distribution
00853909006358PrimaryGS10
00853909006280Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853909006488008539090064888539090064880853909006488
00853909006358008539090063588539090063580853909006358
00853909006280008539090062808539090062800853909006280

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Width21Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature50 Degrees Fahrenheit85 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+1 (713) 682-3185info@dermaquik.com

Regulatory Flags#

DUNS number
043924405
Device count
2
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853909006198DermaClipLarge 3 Clip Extreme610052023-04-20
00853909006365DermaQuikSport & Extreme Wound Closure Kit625522023-04-21
00853909006488DermaQuikHome & Field Wound Closure Kit625512023-04-21
00853909006495DermaQuikSport & Extreme Wound Closure Kit625522023-04-21
00853909006112DermaClipLarge 3 Clip610042023-04-20
00853909006150DermaClipRegular 5 Clip610022023-04-20
00853909006167DermaClipLarge 1 Clip610032023-04-20
00853909006228DermaClipLarge 1 Clip Extreme610062023-04-20
00853909006075DermaClipRegular 2 Clip610012023-04-20
00853909006129DermaClipLarge 3 Clip610042023-04-20
00853909006105DermaClipRegular 5 Clip610022023-04-20
00853909006174DermaClipLarge 1 Clip610032023-04-20
00853909006204DermaClipLarge 3 Clip Extreme610052023-04-20
00853909006235DermaClipLarge 1 Clip Extreme610062023-04-20
00853909006518DermaQuikHome & Field 3 Multi-pouch625312023-04-20
00853909006525DermaQuikSport & Extreme 3 Multi-pouch625322023-04-20