FDA.reportPublic FDA data

Jac-cell USA Inc.

Primary DI
B461JAU97971
Brand
Jac-cell USA Inc.
Company
JAC CELL USA INC
Model
JAU-9797
Device description
SAF-T-VAC Smoke and Fluid Evacuator
Published
2017-06-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

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
K170582000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170582000Saf-T-Vac Smoke and Fluid EvacuatorSurgical Technology Laboratories, Inc.2017-04-14GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B461JAU97971PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical plume evacuation system tubeA sterile, long, hollow cylinder which, as part of a surgical smoke evacuation system, is used to capture and conduct to exhaust the plume generated during open surgical procedures in which there is tissue ablation (e.g., laser surgery, electrocautery, electrosurgical diathermy device). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
015023538
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B461JAU11591Jac-cell USA In.cJAU-11592017-02-27
B461JAU116012Jac-cell USA IncJAU-11602017-02-27
B461JAU11681Jac-cell USA Inc.JAU-11682017-02-27
B461JAU117013Jac-cell USA Inc.JAU-11702017-03-30
B461JAU142000Jac-cell USAJAU-14202018-08-30
B461JAU142011Jac-cell USAJAU-14202018-08-30
B461JAU142213Jac-cell USA Inc.JAU-14222017-02-15
B461JAU15201Jac-cell USA Inc.JAU-15202017-06-28
B461JAU3092R0Jac-cell USA Inc.JAU-3092-R2017-06-28

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Primary DI, Brand, Company table
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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