FDA.reportPublic FDA data

InterPulse

Primary DI
37613154730217
Brand
InterPulse
Company
STRYKER CORPORATION
Model
0210918000
Catalog number
0210918000
Device description
Handpiece Set with Fan Spray Tip and Suction Tube
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
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FQHLAVAGE, JET

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQHLavage, JetGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
37613154730217PackageGS16In Commercial Distribution
07613154730216PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3761315473021737613154730217
07613154730216076131547302167613154730216

GMDN Terms#

Term, Definition table
TermDefinition
Disposable surgical irrigation/aspiration systemA sterile device assembly designed to irrigate, wash, and evacuate debris from general soft-tissue and orthopaedic surgical sites (e.g., for soft-tissue wound or bone debridement, site clearing, bone cement residue removal) with a pulsatile jet of sterile fluid (typically saline). It typically consists of a handpiece with an integral battery-powered pump and irrigation/suction controls, a single-use battery pack, tubing, and detachable tips (applicators) of various shapes and sizes for specific surgical applications. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius40 Degrees Celsius

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
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50382909101206SurgiphorCAREFUSION 2200, INCFQH2026-03-05
10075450844334Hy-Vee Saline Wound WashHY-VEE, INC.FQH2026-02-19
10850073677039Shur-ClensAsept Pak, Inc.FQH2026-02-17
00850073677063Skin-ClensAsept Pak, Inc.FQH2026-02-17
06970462546825Irrigation PumpShenzhen HugeMed Medical Technical Development Co., Ltd.FQH2026-02-10
15051471214788De Soutter MedicalDE SOUTTER MEDICAL LIMITEDFQH2025-09-12
15051471214795De Soutter MedicalDE SOUTTER MEDICAL LIMITEDFQH2025-09-12
15051471217123De Soutter MedicalDE SOUTTER MEDICAL LIMITEDFQH2025-09-12
15051471217130De Soutter MedicalDE SOUTTER MEDICAL LIMITEDFQH2025-09-12
00810025928858Caring Mill Saline Wound WashCaring MillFQH2025-07-03
20850073677005Shur-ClensAsept Pak, Inc.FQH2025-04-30
00860006476038Shur-ClensAsept Pak, Inc.FQH2025-04-23
00842351120040Irrisept Antimicrobial Wound LavageIRRIMAX CORPORATIONFQH2024-07-16
ESUM930081200SutterSutter Medizintechnik GmbHFQH2024-06-24
00817278012020Patriot ProMed Michigan Holdings, LLCFQH2024-06-04
05051471211735De Soutter MedicalDE SOUTTER MEDICAL LIMITEDFQH2024-05-21
05051471211742De Soutter MedicalDE SOUTTER MEDICAL LIMITEDFQH2024-05-21
06951233720125CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720170CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720316CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720330CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720361CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720378palaJet ®Guangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720507palaJet ®Guangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720545CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720569PulsaCleanGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720958PulsaCleanGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720965PulsaCleanGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233721085CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233721108CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11