FDA.reportPublic FDA data

DermaClip

Primary DI
00853909006204
Brand
DermaClip
Company
Dermaclip Us, L.L.C.
Model
Large 3 Clip Extreme
Catalog number
61005
Device description
DermaClip Extreme Large Clip, 3 Pack, 3" Closure, Enhanced Adhesive
Published
2023-04-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGXTape And Bandage, Adhesive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853909006204PackageGS112In Commercial Distribution
00853909006211PackageGS112In Commercial Distribution
00853909006594PackageGS1180In Commercial Distribution
00853909006198PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853909006204008539090062048539090062040853909006204
00853909006211008539090062118539090062110853909006211
00853909006594008539090065948539090065940853909006594
00853909006198008539090061988539090061980853909006198

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@dermaclip.com

Regulatory Flags#

DUNS number
043924405
Device count
1
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
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
00853909006235DermaClipLarge 1 Clip Extreme610062023-04-20
00853909006518DermaQuikHome & Field 3 Multi-pouch625312023-04-20
00853909006525DermaQuikSport & Extreme 3 Multi-pouch625322023-04-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197998095641Transpore™Solventum US LLCKGX2026-09-25
00197998095672Transpore™Solventum US LLCKGX2026-09-25
00197998095702Transpore™Solventum US LLCKGX2026-09-25
00197998095733Transpore™Solventum US LLCKGX2026-09-25
00197998095788Transpore™Solventum US LLCKGX2026-09-25
00197998103612Transpore™Solventum US LLCKGX2026-09-25
00197998103636Transpore™Solventum US LLCKGX2026-09-25
00197998164118Transpore™Solventum US LLCKGX2026-09-25
06979191883744OKTAPEHTT Technologies, Inc.KGX2026-09-02
06979191883751OKTAPEHTT Technologies, Inc.KGX2026-09-02
06979191883768OKTAPEHTT Technologies, Inc.KGX2026-09-02
06979191883775OKTAPEHTT Technologies, Inc.KGX2026-09-02
00850087488785CeeportCEEPORT INC.KGX2026-08-26
00850087488792CeeportCEEPORT INC.KGX2026-08-26
00197998149016Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149047Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149078Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149382Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149412Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149443Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149474Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149504Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998185557Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00029369133334McDavidShock Doctor, Inc.KGX2026-08-18
00050428143216CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-08-18
069740214114323H MedicalWAL-MART STORES, INC.KGX2026-07-31
069740214114943H MedicalWAL-MART STORES, INC.KGX2026-07-31
06979191882112NanacareWAL-MART STORES, INC.KGX2026-07-31
06979191882228NanacareWAL-MART STORES, INC.KGX2026-07-31
06979191882242NanacareWAL-MART STORES, INC.KGX2026-07-31