FDA.reportPublic FDA data

Saf-T-Vac Smoke and Fluid Evacuator

Primary DI
00851988007983
Brand
Saf-T-Vac Smoke and Fluid Evacuator
Company
SURGICAL TECHNOLOGY LABORATORIES INC
Model
ST9000S
Catalog number
ST9000S
Published
2017-07-06
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

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
00851988007983PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851988007983008519880079838519880079830851988007983

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
080380106
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854804007006SFAMSFAM603SFAM6032017-01-05
00854804007013SFAMSFAM803SFAM8032017-01-05
00854804007037SFAMSFAM503SFAM5032017-01-05
00854804007259SFAM PledgetPLG-6-RD2025-07-15
00854804007129SurgiPlast Nasal SplintSurgiPlast - Large - Skin Color - 1.6mm2024-09-30
00854804007136SurgiPlast Nasal SplintSurgiPlast - Large - Skin Color - 2.0mm2024-09-30
00854804007143SurgiPlast Nasal SplintSurgiPlast - Large - White Color - 1.6mm2024-09-30
00854804007150SurgiPlast Nasal SplintSurgiPlast - Large - White Color - 2.0mm2024-09-30
00854804007167SurgiPlast Nasal SplintSurgiPlast - Small - Skin Color - 1.6mm2024-09-30
00854804007174SurgiPlast Nasal SplintSurgiPlast - Small - Skin Color - 2.0mm2024-09-30
00854804007198SurgiPlast Nasal SplintSurgiPlast - Small - White Color - 1.6mm2024-09-30
00854804007204SurgiPlast Nasal SplintSurgiPlast - Small - White - 2.0mm2024-09-30
00854804007211SurgiPlast Nasal SplintSurgiPlast - Square - Skin Color - 1.6mm2024-09-30
00854804007228SurgiPlast Nasal SplintSurgiPlast - Square - Skin Color - 2.0mm2024-09-30
00854804007235SurgiPlast Nasal SplintSurgiPlast - Square - White Color - 1.6mm2024-09-30
00854804007242SurgiPlast Nasal SplintSurgiPlast - Square - White Color - 2.0mm2024-09-30
00854804007068PureForm6PN01*6PN01*2021-08-30
00854804007075PureForm4PN01*4PN01*2021-08-30
00854804007082PureForm5PN01*5PN01*2021-08-30
00850987007079PureForm2NDP012NDP012016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197998302718Solventum™Solventum US LLCGEI2026-09-25
00724995269586Snowden-PencerSTERIS Deutschland GmbHGEI2026-09-25
00724995269951Snowden-PencerSTERIS Deutschland GmbHGEI2026-09-25
00724995269968Snowden-PencerSTERIS Deutschland GmbHGEI2026-09-25
00190776432300MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432317MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432324MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432430MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432447MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432454MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776431457MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776432041MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776432195MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776432201MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776431181MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431198MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431204MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431211MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431228MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431235MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431242MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431259MillenniumAvalign Technologies, Inc.GEI2026-09-21
10840113236852BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113236890BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113236937BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237040BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237064BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237101BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237118BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237132BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21