FDA.reportPublic FDA data

DermaQuik

Primary DI
00853909006525
Brand
DermaQuik
Company
Dermaclip Us, L.L.C.
Model
Sport & Extreme 3 Multi-pouch
Catalog number
62532
Device description
"DermaQuik Sport & Extreme, OTC, Enhanced Adhesive. 3 Packages in waterproof pouch. Each package contains 1 DermaQuik device which will close 1"" of wound."
Published
2023-04-20
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#

Product Codes#

Code, Name table
CodeName
PYOTape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PYOTape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc UseGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853909006525PrimaryGS10
00853909006297Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853909006525008539090065258539090065250853909006525
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
3
Premarket exempt
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
00853909006358DermaQuikHome & Field Wound Closure Kit625512023-04-21
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971257033698Tape and bandage, adhesive, adjustable closing mechanism, OTC useWeihai Kangzheng Medical Equipment Technology Co., LtdPYO2024-06-22
06971257033704Tape and bandage, adhesive, adjustable closing mechanism, OTC useWeihai Kangzheng Medical Equipment Technology Co., LtdPYO2024-06-22
06971257033773Tape and bandage, adhesive, adjustable closing mechanism, OTC useWeihai Kangzheng Medical Equipment Technology Co., LtdPYO2024-06-22
06971257033780Tape and bandage, adhesive, adjustable closing mechanism, OTC useWeihai Kangzheng Medical Equipment Technology Co., LtdPYO2024-06-22
06971257033797Tape and bandage, adhesive, adjustable closing mechanism, OTC useWeihai Kangzheng Medical Equipment Technology Co., LtdPYO2024-06-22
06971257033803Tape and bandage, adhesive, adjustable closing mechanism, OTC useWeihai Kangzheng Medical Equipment Technology Co., LtdPYO2024-06-22
06971257033810Tape and bandage, adhesive, adjustable closing mechanism, OTC useWeihai Kangzheng Medical Equipment Technology Co., LtdPYO2024-06-22
06971257033827Tape and bandage, adhesive, adjustable closing mechanism, OTC useWeihai Kangzheng Medical Equipment Technology Co., LtdPYO2024-06-22
06971257033834Tape and bandage, adhesive, adjustable closing mechanism, OTC useWeihai Kangzheng Medical Equipment Technology Co., LtdPYO2024-06-22
06971257033841Tape and bandage, adhesive, adjustable closing mechanism, OTC useWeihai Kangzheng Medical Equipment Technology Co., LtdPYO2024-06-22
00840118608978ENDURE INDUSTRIESENDURE INDUSTRIESPYO2024-03-26
00840118602273ENDURE INDUSTRIESENDURE INDUSTRIESPYO2024-03-26
00853909006518DermaQuikDermaclip Us, L.L.C.PYO2023-04-20
00350770003757ANCORIS*Avanos Medical, Inc.PYO2022-10-05
00350770003764ANCORIS*Avanos Medical, Inc.PYO2022-10-05
00350770003771ANCORIS*Avanos Medical, Inc.PYO2022-10-05
00350770003788ANCORIS*Avanos Medical, Inc.PYO2022-10-05
00350770003795ANCORIS*Avanos Medical, Inc.PYO2022-10-05
10350770003754ANCORIS*Avanos Medical, Inc.PYO2022-10-05
10350770003761ANCORIS*Avanos Medical, Inc.PYO2022-10-05
10350770003778ANCORIS*Avanos Medical, Inc.PYO2022-10-05
10350770003785ANCORIS*Avanos Medical, Inc.PYO2022-10-05
10350770003792ANCORIS*Avanos Medical, Inc.PYO2022-10-05
00842071131036CINCHAPPLIED MEDICAL TECHNOLOGY, INC.PYO2022-03-30
00842071131043CINCHAPPLIED MEDICAL TECHNOLOGY, INC.PYO2022-03-30
00860001701098PharmChem, Inc. Transparent Overlay Film with CutoutPHARMCHEM, INC.PYO2021-08-26
00860002279626PharmChem, Inc. Transparent Overlay Film with CutoutPHARMCHEM, INC.PYO2021-08-26
00842071130930CINCHAPPLIED MEDICAL TECHNOLOGY, INC.PYO2020-11-04
00842071130947CINCHAPPLIED MEDICAL TECHNOLOGY, INC.PYO2020-11-04
00842071130954CINCHAPPLIED MEDICAL TECHNOLOGY, INC.PYO2020-11-04