FDA.reportPublic FDA data

Medline

Primary DI
20888277371801
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
GC000RFR
Catalog number
GC000RFR
Device description
GC000RF @RELIEVA FLEX SINUS GUIDE CAT (Y
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
KAMCANNULA, SINUS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAMCannula, SinusGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888277371801PackageGS15In Commercial Distribution
10888277371804PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088827737180120888277371801
1088827737180410888277371804

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B390197230FLA1Reprocessed 4mm EndoScrub Sheath, 45 deg, K StorzSURETEK MEDICALKAM2026-04-30
09348811099082INKAThe Trustee for KAISER FAMILY TRUSTKAM2025-11-28
09348811099099INKAThe Trustee for KAISER FAMILY TRUSTKAM2025-11-28
09348811099112INKAThe Trustee for KAISER FAMILY TRUSTKAM2025-11-28
09348811099129INKAThe Trustee for KAISER FAMILY TRUSTKAM2025-11-28
04250381847145Cannula for Krause ear polyps snareSpiggle & Theis Medizintechnik GmbHKAM2025-10-10
04250676721075Eicken antrum cannulaSpiggle & Theis Medizintechnik GmbHKAM2025-10-05
04250676745132Cannula RegensburgSpiggle & Theis Medizintechnik GmbHKAM2025-10-05
04250676740618Laryngeal cannulaSpiggle & Theis Medizintechnik GmbHKAM2025-09-12
00757770420797Bausch + LombBausch & Lomb IncorporatedKAM2025-08-15
00757770683505Bausch + LombBausch & Lomb IncorporatedKAM2025-08-05
00194613023133MSI Precision Specialty InstrumentsMed Saver, Inc.KAM2025-08-01
00194613102364MSI Precision Specialty InstrumentsMed Saver, Inc.KAM2025-08-01
00194613102388MSI Precision Specialty InstrumentsMed Saver, Inc.KAM2025-08-01
00194613107444MSI Precision Specialty InstrumentsMed Saver, Inc.KAM2025-08-01
00194613107451MSI Precision Specialty InstrumentsMed Saver, Inc.KAM2025-08-01
00194613108571MSI Precision Specialty InstrumentsMed Saver, Inc.KAM2025-08-01
B3901912038T1Reprocessed 4mm EndoScrub 2 Sheath, 0 deg, w/TubingSURETEK MEDICALKAM2025-05-01
B390197230CVA1Reprocessed 4mm EndoScrub Sheath, 70 deg, K StorzSURETEK MEDICALKAM2025-04-25
00194613065379MSI Precision Specialty InstrumentsMed Saver, Inc.KAM2025-03-21
00194613102371MSI Precision Specialty InstrumentsMed Saver, Inc.KAM2025-03-21
00194613102746MSI Precision Specialty InstrumentsMed Saver, Inc.KAM2025-03-21
00194613108502MSI Precision Specialty InstrumentsMed Saver, Inc.KAM2025-03-21
10080196392278MEDLINEMEDLINE INDUSTRIES, INC.KAM2025-02-14
10888277371774MEDLINEMEDLINE INDUSTRIES, INC.KAM2025-02-14
20080196392275MEDLINEMEDLINE INDUSTRIES, INC.KAM2025-02-14
20888277371771MEDLINEMEDLINE INDUSTRIES, INC.KAM2025-02-14
04250676742360Suction tubeSpiggle & Theis Medizintechnik GmbHKAM2024-12-27
08904461006835OSSEOUS Suction Tube for Sinus-DisposableEON MEDITECH PRIVATE LIMITEDKAM2024-07-03
08904461006842OSSEOUS Suction Tube for Sinus-DisposableEON MEDITECH PRIVATE LIMITEDKAM2024-07-03