FDA.reportPublic FDA data

Stryker KWIC Needle

Primary DI
00808232001365
Brand
Stryker KWIC Needle
Company
Stryker Corporation
Model
6002-070-000
Catalog number
6002-070-000
Device description
K-wire Insertion Cannualted Needle, Trocar Tip
Published
2016-09-24
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HAWNeurological stereotaxic Instrument
KNWINSTRUMENT, BIOPSY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAWNeurological Stereotaxic InstrumentNeurology2
KNWInstrument, BiopsyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140868000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140868000STRYKER KWIC NEEDLEOrthovita, Inc.2014-06-05HAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00808232001365PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00808232001365008082320013658082320013650808232001365

GMDN Terms#

Term, Definition table
TermDefinition
Body aspiration needle, single-useA sterile, sharp bevel-edged, hollow tubular metal instrument designed to remove fluid from a body cavity or to obtain a biopsy specimen from a patient through aspiration; it is not dedicated to a particular part of the anatomy. The device is typically longer than a hypodermic needle and usually has a wider hub. It is not intended for administration of pharmaceuticals. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length15Centimeter
Needle Gauge8Gauge

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature20 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(610)640-1775inst.stryker.cs@stryker.com

Regulatory Flags#

DUNS number
149183167
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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04546540434388PCD SpinePlex05055830000505-583-0002015-09-24
04546540434395PCD SpinePlex05055850000505-585-0002015-09-24
04546540434401PCD SpinePlex05055860000505-586-0002015-09-24
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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810131882983BMAN BCOR Bone Marrow Aspirate KitSurgentec, LLCKNW2026-08-19
00810131884697BMAN BCOR Bone Marrow Aspirate Kit (with Clip)Surgentec, LLCKNW2026-08-19
00884450476079CorVocet™Merit Medical Systems, Inc.KNW2026-08-18
00884450476093CorVocet™Merit Medical Systems, Inc.KNW2026-08-18
07340201503683Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2026-08-18
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07340201503720Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2026-08-18
07340201503744Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2026-08-18
07340201503768Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2026-08-18
07340201503942Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2026-08-18
07340201503959Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2026-08-18
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06937278635068CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
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06937278635112CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
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