FDA.reportPublic FDA data

NA

Primary DI
37613154495598
Brand
NA
Company
STRYKER CORPORATION
Model
0700020000S1
Catalog number
0700020000S1
Device description
Low Pressure 4-Port Manifold
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FYDAPPARATUS, EXHAUST, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FYDApparatus, Exhaust, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
37613154495598PackageGS110In Commercial Distribution
07613154495597PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3761315449559837613154495598
07613154495597076131544955977613154495597

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
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 DI, Brand, Model table
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

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Primary DI, Brand, Company table
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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
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20193489085355MedlineMEDLINE INDUSTRIES, INC.FYD2023-02-22
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00840319734520Hayden MedicalHayden Medical, Inc.FYD2022-09-12
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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