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
00190776408718MillenniumAvalign Technologies, Inc.GEI2026-08-03
00190776422677MillenniumAvalign Technologies, Inc.GEI2026-08-03
00190776422820MillenniumAvalign Technologies, Inc.GEI2026-08-03
B382SD5657815600Surgical DirectSurgical Direct, Inc.GEI2026-08-03
00190776407445MillenniumAvalign Technologies, Inc.GEI2026-07-31
00190776422332MillenniumAvalign Technologies, Inc.GEI2026-07-31
00190776422516MillenniumAvalign Technologies, Inc.GEI2026-07-31
00198506092640ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-29
00198506093562ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-29
07613327688849MalisSTRYKER CORPORATIONGEI2026-07-29
07613327688856MalisSTRYKER CORPORATIONGEI2026-07-29
07613327688979MalisSTRYKER CORPORATIONGEI2026-07-29
07613327688986MalisSTRYKER CORPORATIONGEI2026-07-29
08800020110688INTRAGen HandpieceJeisys Medical Inc.GEI2026-07-29
B354OSRP80Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP81Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP82Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP83Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP84Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP85Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP89Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
00190776407285MillenniumAvalign Technologies, Inc.GEI2026-07-28
00190776407292MillenniumAvalign Technologies, Inc.GEI2026-07-28
00198506092770ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092886ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092893ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092909ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092916ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092954ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092961ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28