FDA.report

NA

Primary DI
34546540916618
Brand
NA
Company
STRYKER CORPORATION
Model
0700021000
Catalog number
0700021000
Device description
Smoke Evacuator HEPA/Charcoal Filter
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FYDAPPARATUS, EXHAUST, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
FYDApparatus, Exhaust, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
34546540916618PackageGS14In Commercial Distribution
04546540916617PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
3454654091661834546540916618
04546540916617045465409166174546540916617

GMDN Terms

TermDefinition
Surgical fluid/smoke waste management systemAn assembly of devices designed to collect and dispose of both surgical fluid waste and plume smoke generated by surgical procedures involving electrosurgical diathermy, electrocautery, or a laser. It typically consists of a mains electricity (AC-powered) mobile suction unit and a fixed disposal unit. The suction unit uses negative pressure at the site of intervention to collect/filter the fluid/smoke in its containers and filters; it is attached to the disposal unit for automatic container emptying and cleaning. The system is used in the operating room (OR), pathology and surgical centres, and doctor's offices to minimize healthcare worker exposure to harmful fluids/smoke.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)253-3210Inst.Stryker.cs@Stryker.com

Regulatory Flags

DUNS number
196548481
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
07613327687637N/A65170400166517-040-0162026-03-19
07613327687644N/A65170400106517-040-0102026-03-19
07613327687651N/A65170700216517-070-0212026-03-19
07613327687668N/A65170480216517-048-0212026-03-19
07613327687675N/A65170400126517-040-0122026-03-19
07613327628357RPS88080000008808-000-0002025-10-01
07613327656763BPX79000120007900-012-0002026-03-04
07613327656770BPX79000130007900-013-0002026-03-04
07613327657760BPX79000340007900-034-0002026-03-04
07613327657777BPX79000150007900-015-0002026-03-04
07613327657784BPX79000310007900-031-0002026-03-04
07613327657791BPX79000990007900-099-0002026-03-04
07613327657807N/A79003760107900-376-0102026-03-04
07613327657814BPX79000370007900-037-0002026-03-04
07613327657821N/A79003770107900-377-0102026-03-04
07613327657838N/A79003780107900-378-0102026-03-04
07613327659429BPX79000250007900-025-0002026-03-04
37613327693288Malis6760-180-0106760-180-010-Z012026-02-25
37613327693295Malis6760-180-0056760-180-005-Z012026-02-25
37613327693363Malis6760-180-0156760-180-015-Z012026-02-25

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10705036046523MegadyneMEGADYNE MEDICAL PRODUCTS, INC.FYD2025-06-18
30653405990196PlumeSafe® X5™Conmed CorporationFYD2024-08-13
10653405987550PlumeSafe® X5™Conmed CorporationFYD2024-08-12
10653405987994PlumeSafe® X5™Conmed CorporationFYD2024-08-12
10653405988007PlumeSafe® X5™Conmed CorporationFYD2024-08-12
30653405987561PlumeSafe® X5™Conmed CorporationFYD2024-08-12
30653405988018PlumeSafe® X5™Conmed CorporationFYD2024-08-12
00845854081757CooperSurgicalConmed CorporationFYD2024-03-25
00845854081641PLUMEGUARDConmed CorporationFYD2023-12-05
00845854081924CONMEDConmed CorporationFYD2023-12-05
30845854053106MINIVACConmed CorporationFYD2023-12-01
00845854080965CONMEDConmed CorporationFYD2023-12-01
30845854081147CYNOSUREConmed CorporationFYD2023-06-16
00817688021902Crystal VisionI.C. MEDICAL, INC.FYD2023-03-06
30193489085345MedlineMEDLINE INDUSTRIES, INC.FYD2023-02-22
20193489085355MedlineMEDLINE INDUSTRIES, INC.FYD2023-02-22
00817183020660NEBULAE SRS Tubing SetNORTHGATE TECHNOLOGIES INC.FYD2023-02-14
00817183020684NEBULAE SRS Laparoscopic Surgical PumpNORTHGATE TECHNOLOGIES INC.FYD2023-02-14
00840319734520Hayden MedicalHayden Medical, Inc.FYD2022-09-12
00840319734537Hayden MedicalHayden Medical, Inc.FYD2022-09-12
10653405002543NAConmed CorporationFYD2022-06-02
30653405988124Foot switch for FUMOVAC 900Conmed CorporationFYD2022-03-30
20845854082543Pneumatic Footswitch for PlumeVac™ Smoke Plume EvacuatorConmed CorporationFYD2021-12-20
30845854081116CYNOSUREConmed CorporationFYD2021-11-26
10845854648599TeleVac2Conmed CorporationFYD2021-11-08
30653405987622OR-VACConmed CorporationFYD2021-10-27
00817688022978STERISI.C. MEDICAL, INC.FYD2021-10-19
00817688022985STERISI.C. MEDICAL, INC.FYD2021-10-19
00817688023005STERISI.C. MEDICAL, INC.FYD2021-10-19
00817688023012STERISI.C. MEDICAL, INC.FYD2021-10-19