FDA.reportPublic FDA data

NA

Primary DI
34546540144165
Brand
NA
Company
STRYKER CORPORATION
Model
0210010000
Catalog number
0210010000
Device description
Bone Cleaning Tip
Published
2015-09-24
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
CACAPPARATUS, AUTOTRANSFUSION
FQHLAVAGE, JET

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CACApparatus, AutotransfusionAnesthesiology2
FQHLavage, JetGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
34546540144165PackageGS112In Commercial Distribution
04546540144164PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3454654014416534546540144165
04546540144164045465401441644546540144164

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation handpiece nozzleA sterile device designed to be attached to the distal end of a lavage system or kit handpiece to function as an applicator/nozzle that produces an intentional jet, stream or spray of sterile fluid (typically saline) from its aperture to the site of operation during a surgical intervention (e.g., trauma, soft tissue application and orthopaedic) for the purpose of removing tissue, bone debridement and/or bone cement residue, and to clean the site. It is available in many designs, shapes and sizes, including a fan spray, shower spray, high capacity with multiple aperture spray; some have a built-in filter, splash shield, or brush. 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
+0118002533210inst.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
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
34026704912200PLEUR-EVACTELEFLEX INCORPORATEDCAC2025-09-17
34026704912217PLEUR-EVACTELEFLEX INCORPORATEDCAC2025-09-17
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
34026704911791PLEUR-EVACTELEFLEX INCORPORATEDCAC2025-09-04
34026704911807PLEUR-EVACTELEFLEX INCORPORATEDCAC2025-09-04
00810025928858Caring Mill Saline Wound WashCaring MillFQH2025-07-03
30812747014100HAEMONETICS CELL SAVER ELITE+ SYSTEMHAEMONETICS CORPORATIONCAC2025-06-12
20850073677005Shur-ClensAsept Pak, Inc.FQH2025-04-30
44026704911866PLEUR-EVACTELEFLEX INCORPORATEDCAC2025-04-29
00860006476038Shur-ClensAsept Pak, Inc.FQH2025-04-23
18033178113707XTRASORIN GROUP ITALIA SRLCAC2024-12-20
38033178113725XTRASORIN GROUP ITALIA SRLCAC2024-12-20
38033178113756XTRASORIN GROUP ITALIA SRLCAC2024-12-20
38033178113763XTRASORIN GROUP ITALIA SRLCAC2024-12-20
38033178113923XTRASORIN GROUP ITALIA SRLCAC2024-12-20
38033178113930XTRASORIN GROUP ITALIA SRLCAC2024-12-20
38033178113947XTRASORIN GROUP ITALIA SRLCAC2024-12-20
38033178113954XTRASORIN GROUP ITALIA SRLCAC2024-12-20
38033178113985XTRASORIN GROUP ITALIA SRLCAC2024-12-20
38033178113992XTRASORIN GROUP ITALIA SRLCAC2024-12-20
38033178114005XTRASORIN GROUP ITALIA SRLCAC2024-12-20
38033178114036XTRASORIN GROUP ITALIA SRLCAC2024-12-20