FDA.reportPublic FDA data

WavelinQ

Primary DI
00801741218033
Brand
WavelinQ
Company
CLEARSTREAM TECHNOLOGIES LIMITED
Model
ESU2
Catalog number
ESU2
Device description
WavelinQ Generator
Published
2022-11-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, cutting & coagulation & accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222793000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222793000WavelinQ™ GeneratorC.R. Bard, Inc.2022-10-17GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00801741218033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00801741218033008017412180338017412180330801741218033

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical system generatorA mains electricity-powered (AC-powered) component of a electrosurgical system intended to generate radio-frequency (RF) electrical current for subsequent cutting and coagulation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system generator). It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for argon-enhanced electrosurgery.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)562-0027medical.services@crbard.com
+1(800)321-4254medical.services@crbard.com

Regulatory Flags#

DUNS number
989214291
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00801741184802Halo One™ Thin-Walled Guiding SheathHLO41018FHHLO41018FH2020-04-27
00801741184819Halo One™ Thin-Walled Guiding SheathHLO41035FHHLO41035FH2020-04-27
00801741184833Halo One™ Thin-Walled Guiding SheathHLO51018FHHLO51018FH2020-04-27
00801741184840Halo One™ Thin-Walled Guiding SheathHLO51035FHHLO51035FH2020-04-27
00801741184864Halo One™ Thin-Walled Guiding SheathHLO61035FHHLO61035FH2020-04-27
00801741223778Halo One Thin-Walled Guiding SheathHLO41018FHKHLO41018FHK2021-12-14
00801741223785Halo One Thin-Walled Guiding SheathHLO41035FHKHLO41035FHK2021-12-14
00801741223815Halo One Thin-Walled Guiding SheathHLO51018FHKHLO51018FHK2021-12-14
00801741223822Halo One Thin-Walled Guiding SheathHLO51035FHKHLO51035FHK2021-12-14
00801741223853Halo One Thin-Walled Guiding SheathHLO61035FHKHLO61035FHK2021-12-14
00801741223907Halo One Thin-Walled Guiding SheathHLO61018FHKHLO61018FHK2021-12-14
00801741184826Halo One™ Thin-Walled Guiding SheathHLO42535HHLO42535H2020-04-27
00801741184857Halo One™ Thin-Walled Guiding SheathHLO52535HHLO52535H2020-04-27
00801741184871Halo One™ Thin-Walled Guiding SheathHLO62535HHLO62535H2020-04-27
00801741223792Halo One Thin-Walled Guiding SheathHLO42518HKHLO42518HK2021-12-14
00801741223808Halo One Thin-Walled Guiding SheathHLO42535HKHLO42535HK2021-12-14
00801741223839Halo One Thin-Walled Guiding SheathHLO52518HKHLO52518HK2021-12-14
00801741223846Halo One Thin-Walled Guiding SheathHLO52535HKHLO52535HK2021-12-14
00801741223860Halo One Thin-Walled Guiding SheathHLO62535HKHLO62535HK2021-12-14
00801741223914Halo One Thin-Walled Guiding SheathHLO62518HKHLO62518HK2021-12-14

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776398484MillenniumAvalign Technologies, Inc.GEI2026-07-16
08800020100276INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100283INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100306INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100313INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100320INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100337INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020104984DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020104991DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105004DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105059DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105066DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105073DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020106827DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020107626DENSITY HandpieceJeisys Medical Inc.GEI2026-07-16
08800020107633DENSITY HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110565INTRAcel HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110572INTRAcel HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110640FootswitchJeisys Medical Inc.GEI2026-07-16
B382SD08890310101D0Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD08890320101D0Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD7720520001Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD7720585030Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD84032220032B0Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD8406210032B0Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD89029200Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD89039060Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD89139290Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD8917450Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD89179290Surgical DirectSurgical Direct, Inc.GEI2026-07-14