FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
10195327493202
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
RFA161010CSL
Catalog number
RFA161010CSL
Device description
NDL RFCRV SHRP 16GX10CMX10MM
Published
2024-01-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXIProbe, radiofrequency lesion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXIProbe, Radiofrequency LesionNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K032196000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032196000NBD DISPOSABLE RF CANNULAENew Business Development, LLC2003-10-09GXI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40195327493203PackageGS125In Commercial Distribution
10195327493202PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019532749320340195327493203
1019532749320210195327493202

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463customerservice@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10080196320493MEDLINEMDS30201MDS302012026-09-04
10080196320516MEDLINEMDS30203MDS302032026-09-05
10197344039418HUDSON RCIHUD99001KITHUD99001KIT2026-09-04
10197344043064HUDSON RCIHUD99060KITHUD99060KIT2026-09-04
10197344043071HUDSON RCIHUD99060HUD990602026-09-04
10197344043101HUDSON RCIHUD99018KITHUD99018KIT2026-09-04
10197344043118HUDSON RCIHUD99009KITHUD99009KIT2026-09-04
10197344148332MEDLINERTDCIDDHNRTDCIDDHN2026-09-04
10197344148707MEDLINERTDCIVOMRRTDCIVOMR2026-09-04
10197344204540MEDLINEMDSDAMPLGMDSDAMPLG2026-09-04
10197344204557MEDLINEMDSDAMPMGMDSDAMPMG2026-09-04
10197344204564MEDLINEMDSDAMPXLGMDSDAMPXLG2026-09-04
10888277415010MEDLINEAEG001SAEG001S2026-09-04
10888277415027MEDLINEAEG017SAEG017S2026-09-04
10080196304752MEDLINEDYNJP2203SDYNJP2203S2016-10-14
10080196714100MEDLINEDYNJP2003DYNJP20032016-10-14
10080196894536MEDLINEDYNJP6010DYNJP60102021-01-26
10884389106280MEDLINEDYND70279DYND702792023-01-27
20888277699561MEDLINENONLV340NONLV3402020-12-04
10884389393697Medline Industries, Inc.DYNJASM1DYNJASM12019-01-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048223070291RGNPajunk GmbH MedizintechnologieGXI2026-06-10
04048223070321RGNPajunk GmbH MedizintechnologieGXI2026-06-10
04048223070727RFTLPajunk GmbH MedizintechnologieGXI2026-06-10
04048223070758RFTLPajunk GmbH MedizintechnologieGXI2026-06-10
04048223070772RFTLPajunk GmbH MedizintechnologieGXI2026-06-10
04048223084939ChibaPajunk GmbH MedizintechnologieGXI2026-06-10
04048223085257ChibaPajunk GmbH MedizintechnologieGXI2026-06-10
04048223085264ChibaPajunk GmbH MedizintechnologieGXI2026-06-10
04048223085387ChibaPajunk GmbH MedizintechnologieGXI2026-06-10
04048223085394ChibaPajunk GmbH MedizintechnologieGXI2026-06-10
04048223085424ChibaPajunk GmbH MedizintechnologieGXI2026-06-10
04048223085431ChibaPajunk GmbH MedizintechnologieGXI2026-06-10
04048223085448ChibaPajunk GmbH MedizintechnologieGXI2026-06-10
04048223085455ChibaPajunk GmbH MedizintechnologieGXI2026-06-10
10884450452346ViaVerte™Merit Medical Systems, Inc.GXI2026-05-19
07613327601121OptaBlateSTRYKER CORPORATIONGXI2025-05-27
07613327601169OptaBlateSTRYKER CORPORATIONGXI2025-05-27
10195327666354Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GXI2024-11-03
M661SST221505Radiofrequency (RF) NeedleSpectra Medical Devices, LLCGXI2024-06-18
10195327493172Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GXI2024-01-07
10195327493189Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GXI2024-01-07
20763000835631AccurianMEDTRONIC SOFAMOR DANEK, INC.GXI2023-09-25
20763000835648AccurianMEDTRONIC SOFAMOR DANEK, INC.GXI2023-09-25
20763000835655AccurianMEDTRONIC SOFAMOR DANEK, INC.GXI2023-09-25
00852454006240IntraceptRelievant Medsystems, Inc.GXI2023-04-20
00852454006257IntraceptRelievant Medsystems, Inc.GXI2023-04-20
10195327047030Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GXI2022-08-04
00193493000265COOLIEF*Avanos Medical, Inc.GXI2022-03-17
00193493000272COOLIEF*Avanos Medical, Inc.GXI2022-03-17
00193493000296AVANOS*Avanos Medical, Inc.GXI2022-03-12