FDA.reportPublic FDA data

DermaQuik

Primary DI
00853909006495
Brand
DermaQuik
Company
Dermaclip Us, L.L.C.
Model
Sport & Extreme Wound Closure Kit
Catalog number
62552
Device description
DermaQuik Sport & Extreme Wound Closure Kit, OTC. Waterproof kit includes 2 Packages of DermaQuik Sport & Extreme Devices (1 Clip per Package, 1" Closure per Package), Enhanced 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
Rx
false
OTC
true
Sterile
true
Single use
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853909006495PackageGS136In Commercial Distribution
00853909006365PrimaryGS10
00853909006297Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853909006495008539090064958539090064950853909006495
00853909006365008539090063658539090063650853909006365
00853909006297008539090062978539090062970853909006297

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
043924405
Device count
2
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
00853909006198DermaClipLarge 3 Clip Extreme610052023-04-20
00853909006358DermaQuikHome & Field Wound Closure Kit625512023-04-21
00853909006365DermaQuikSport & Extreme Wound Closure Kit625522023-04-21
00853909006488DermaQuikHome & Field Wound Closure Kit625512023-04-21
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