FDA.reportPublic FDA data

AccuMark

Primary DI
07613327115987
Brand
AccuMark
Company
STRYKER CORPORATION
Model
0920182000
Catalog number
0920182000
Device description
Chiba w/ Accumark
Published
2016-09-23
Public version status
Update
Distribution status
Not 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
MJGDEVICE, PERCUTANEOUS, BIOPSY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MJGDevice, Percutaneous, BiopsyGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
37613327115988PackageGS120Not in Commercial Distribution
07613327115987PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3761332711598837613327115988
07613327115987076133271159877613327115987

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
Length20Centimeter
Needle Gauge18Gauge

Contacts#

Phone, Email table
PhoneEmail
+1(800)253-3210Inst.Stryker.cs@Stryker.com

Regulatory Flags#

DUNS number
196548481
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327625172Steri-Shield04248010000424-801-0002025-02-21
07613327625257Steri-Shield04247212000424-721-2002025-02-21
07613327625288Steri-Shield04247412000424-741-2002025-02-21
07613327625295Steri-Shield04248211000424-821-1002025-02-21
07613327625332Steri-Shield04248212000424-821-2002025-02-21
07613327625349Steri-Shield04248312000424-831-2002025-02-21
07613327625363Steri-Shield04248512000424-851-2002025-02-21
07613327625370Steri-Shield04249210000424-921-0002025-02-21
07613327625387Steri-Shield04249410000424-941-0002025-02-21
07613327625394Steri-Shield04249510000424-951-0002025-02-21
07613327625400Steri-Shield04249310000424-931-0002025-02-21
07613327625417Steri-Shield04249412000424-941-2002025-02-21
07613327625424Steri-Shield04249311000424-931-1002025-02-21
07613327625431Steri-Shield04249211000424-921-1002025-02-21
07613327625448Steri-Shield04249312000424-931-2002025-02-21
07613327625455Steri-Shield04249512000424-951-2002025-02-21
07613327625462Steri-Shield04249212000424-921-2002025-02-21
07613327625479Steri-Shield04249511000424-951-1002025-02-21
07613327625486Steri-Shield04249411000424-941-1002025-02-21
07613327465655Neptune0703-046-0060703-046-0062019-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956511699CARDINAL HEALTHCardinal Health 200, LLCMJG2026-07-06
10198956133594CARDINAL HEALTHCardinal Health 200, LLCMJG2025-08-28
10198956127555CARDINAL HEALTHCardinal Health 200, LLCMJG2025-07-15
10198956116566CARDINAL HEALTHCardinal Health 200, LLCMJG2025-06-16
10198956084094CARDINAL HEALTHCardinal Health 200, LLCMJG2025-06-11
10197106926802CARDINAL HEALTHCardinal Health 200, LLCMJG2025-06-10
10197106927991CARDINAL HEALTHCardinal Health 200, LLCMJG2025-06-10
10198956017535CARDINAL HEALTHCardinal Health 200, LLCMJG2025-06-05
10198956033542CARDINAL HEALTHCardinal Health 200, LLCMJG2025-06-05
10198956078932CARDINAL HEALTHCardinal Health 200, LLCMJG2025-05-22
10198956015722CARDINAL HEALTHCardinal Health 200, LLCMJG2025-05-09
10198956010109CARDINAL HEALTHCardinal Health 200, LLCMJG2025-04-17
10198956040342CARDINAL HEALTHCardinal Health 200, LLCMJG2025-04-09
10198956001718CARDINAL HEALTHCardinal Health 200, LLCMJG2025-04-07
10197106850770CARDINAL HEALTHCardinal Health 200, LLCMJG2025-04-01
10198956024380CARDINAL HEALTHCardinal Health 200, LLCMJG2025-04-01
10197106838501CARDINAL HEALTHCardinal Health 200, LLCMJG2025-03-20
10197106980699CARDINAL HEALTHCardinal Health 200, LLCMJG2025-03-20
10197106983744CARDINAL HEALTHCardinal Health 200, LLCMJG2025-03-11
10197106963715CARDINAL HEALTHCardinal Health 200, LLCMJG2025-03-06
10197106917138CARDINAL HEALTHCardinal Health 200, LLCMJG2025-02-28
10197106962107CARDINAL HEALTHCardinal Health 200, LLCMJG2025-02-28
10197106933343CARDINAL HEALTHCardinal Health 200, LLCMJG2025-02-26
10197106945278CARDINAL HEALTHCardinal Health 200, LLCMJG2025-02-25
10197106910887CARDINAL HEALTHCardinal Health 200, LLCMJG2025-02-12
10197106924686CARDINAL HEALTHCardinal Health 200, LLCMJG2025-02-10
10197106924013CARDINAL HEALTHCardinal Health 200, LLCMJG2025-02-04
10197106802342CARDINAL HEALTHCardinal Health 200, LLCMJG2025-01-30
10197106914250CARDINAL HEALTHCardinal Health 200, LLCMJG2025-01-30
10197106905951CARDINAL HEALTHCardinal Health 200, LLCMJG2025-01-17