FDA.report

Medline

Primary DI
20888277337029
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
RSM110R
Catalog number
RSM110R
Device description
RSM110 @RELIEVA SPIN BLN SINUPLASTY SYS
Published
2022-05-13
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

Related Records

Contact Domains

Product Codes

CodeName
KAMCANNULA, SINUS

Product Code Classifications

CodeDeviceSpecialtyClass
KAMCannula, SinusGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20888277337029PackageGS15In Commercial Distribution
10888277337022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2088827733702920888277337029
1088827733702210888277337022

GMDN Terms

TermDefinition
Paranasal sinus guide-catheterA sterile cannula-like catheter consisting of a tube with a tip designed to facilitate placement of other devices into or near different sinus ostia. It is used to provide a channel to access the sinus space during diagnostic and therapeutic procedures. This is a single-use device.

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
false
Sterilization required before use
false

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09348811099129INKAThe Trustee for KAISER FAMILY TRUSTKAM2025-11-28
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00194613065379MSI Precision Specialty InstrumentsMed Saver, Inc.KAM2025-03-21
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08906039316452OSSEOUS Suction tubes for Nose ReusableEON MEDITECH PRIVATE LIMITEDKAM2024-06-26
08906039316445OSSEOUS Suction tubes for Nose Reusable EON MEDITECH PRIVATE LIMITEDKAM2024-06-26
08904428747443OSSEOUS Suction tubes for SinusEON MEDITECH PRIVATE LIMITEDKAM2024-06-25
08906039316889OSSEOUS Suction Tubes for Nose DisposableEON MEDITECH PRIVATE LIMITEDKAM2024-06-25