FDA.report

Dermapro

Primary DI
00850002835663
Brand
Dermapro
Company
SAFE N' SIMPLE LLC
Model
SNS57230
Catalog number
SNS57230
Device description
Silicone Adhesive tape 1 inch x 5 yards
Published
2019-08-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
KGXTape And Bandage, Adhesive

Product Code Classifications

CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850002835663PrimaryGS10
00850002835670Unit of UseGS10
00856253007125Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850002835663008500028356638500028356630850002835663
00850002835670008500028356708500028356700850002835670
00856253007125008562530071258562530071250856253007125

GMDN Terms

TermDefinition
Silicone skin adhesive tapeA long and narrow flexible band of plastic, fabric or other material, with an adhesive layer made of soft silicone, designed to cover a surface (e.g., small wound), fix a dressing, or attach objects/devices to the body. The silicone layer is intended to be less allergenic and to allow for easy removal with less trauma to skin and less adhesion to bodily hair than conventional pressure-sensitive adhesives. This is a single-use device.

Device Sizes

TypeValueUnit
Length5Yard
Width1Inch

Sterilization Methods

Method

Contacts

PhoneEmail
2482144877amy@sns-medical.com

Regulatory Flags

DUNS number
807812412
Device count
12
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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