FDA.report

Dermapro

Primary DI
00850004779910
Brand
Dermapro
Company
SAFE N' SIMPLE LLC
Model
SNS57220
Catalog number
SNS57220
Device description
PE Waterproof Adhesive tape 2 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
00850004779910PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850004779910008500047799108500047799100850004779910

GMDN Terms

TermDefinition
Waterproof skin adhesive tapeA long and narrow flexible band that is coated on one side with a pressure-sensitive adhesive, and made from a material designed to resist water permeation, intended to be used to cover a surface (e.g., small wound), fix a dressing, attach objects, and/or exert pressure on a body part; it is not hypoallergenic. This is a single-use device.

Device Sizes

TypeValueUnit
Length5Yard

Sterilization Methods

Method

Contacts

PhoneEmail
2482144877amy@sns-medical.com

Regulatory Flags

DUNS number
807812412
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
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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