FDA.report

Medline

Primary DI
20197344025616
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
RTMSC1415
Catalog number
RTMSC1415
Device description
RETAIL, SILICONE TAPE, 1" X 5.5 YD
Published
2024-03-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

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
10197344025619PackageGS14In Commercial Distribution
20197344025616PackageGS124In Commercial Distribution
00197344025612PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1019734402561910197344025619
2019734402561620197344025616
00197344025612001973440256121973440256120197344025612

GMDN Terms

TermDefinition
Dressing-fixation skin adhesive tape, siliconeA 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.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Protect from freezing, avoid excessive heat.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags

DUNS number
025460908
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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