FDA.reportPublic FDA data

LCCS

Primary DI
04895233601836
Brand
LCCS
Company
LCCS Products Limited
Model
C-1510-S-18-LC
Device description
Single-use RF Cannula
Published
2020-01-01
Public version status
Update
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
GXIProbe, Radiofrequency Lesion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXIProbe, Radiofrequency LesionNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112231000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112231000LCCS INSULATED SPINAL NEEDLE (RF CANNULA)Lccs Products Limited2011-08-19GXI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14895233601833PackageGS125In Commercial Distribution
24895233601830PackageGS1500In Commercial Distribution
64895233601838PackageGS140In Commercial Distribution
04895233601836PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1489523360183314895233601833
2489523360183024895233601830
6489523360183864895233601838
04895233601836048952336018364895233601836

Contacts#

Phone, Email table
PhoneEmail
+1 (844) 743-6449info@lccsmedical.com

Regulatory Flags#

DUNS number
663190222
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04895233601539LCCSC-1510-S-20-LC2021-07-24
04895233606541LCCSSQ22180-LC2020-01-01
04895233611019LCCS3508-LCCS2026-01-13
04895233611026LCCS3406-LCCS2026-01-13
64895233611011LCCS3508-LCCS2026-01-13
64895233611028LCCS3406-LCCS2026-01-13
04895233602369LCCSS-505-20-LC2025-11-17
14895233602366LCCSS-505-20-LC2025-11-17
04895233606565LCCSSQ22155-LC2025-09-15
14895233606562LCCSSQ22155-LC2025-09-15
04895233608149LCCSET20125-LC2025-08-29
14895233608146LCCSET20125-LC2025-08-29
04895233609245LCCSCSE25125-1790-LC2024-06-03
14895233609242LCCSCSE25125-1790-LC2024-06-03
04895233606275LCCSSQE2590-LC2024-06-02
04895233609252LCCSCSE25125-1890-LC2024-06-02
04895233609511LCCSSQE2590-LC2024-06-02
04895233609535LCCSSQE25155-LC2024-06-02
04895233609610LCCSSQE2290-LC2024-06-02
04895233609627LCCSSQE22125-LC2024-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03664539003931SEEG-Tx®DIXI MEDICALGXI2026-11-03
03664539003948SEEG-Tx®DIXI MEDICALGXI2026-11-03
03664539003955SEEG-Tx®DIXI MEDICALGXI2026-11-03
03664539003962SEEG-Tx®DIXI MEDICALGXI2026-11-03
03664539003986SEEG-Tx®DIXI MEDICALGXI2026-11-03
03664539003993SEEG-Tx®DIXI MEDICALGXI2026-11-03
03664539004006SEEG-Tx®DIXI MEDICALGXI2026-11-03
03664539004013SEEG-Tx®DIXI MEDICALGXI2026-11-03
05060224333341EpimedMINTA MEDICAL LIMITEDGXI2026-10-07
05060224334607EpimedMINTA MEDICAL LIMITEDGXI2026-10-07
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