FDA.reportPublic FDA data

Howell

Primary DI
00827002217911
Brand
Howell
Company
COOK INCORPORATED
Model
G21791
Catalog number
HBAN-1-22
Device description
Howell Biliary Aspiration Needle
Published
2016-09-24
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
FCKINSTRUMENT, BIOPSY, SUCTION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCKInstrument, Biopsy, SuctionGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002217911PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002217911008270022179118270022179110827002217911

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dark, dry, cool place.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(812)330-5494sharedservices@cookmedical.com

Regulatory Flags#

DUNS number
079720472
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00827002011939KopansG01193DKBL-20-15.02020-10-02
00827002012585KopansG01258DKBL-21-15.02020-10-02
00827002025547KopansG02554DKBL-21-9.0-A2020-10-02
00827002025868KopansG02586DKBL-20-5.0-A2020-10-02
00827002025875KopansG02587DKBL-20-9.0-A2020-10-02
00827002026018KopansG02601DKBL-20-7.0-A2020-10-02
00827002028500KopansG02850DKBL-20-15.0-A2020-10-02
00827002029002KopansG02900DKBL-21-5.0-A2020-10-02
00827002029385KopansG02938DKBL-21-15.0-A2020-10-02
00827002035072KopansG03507DKBL-21-7.0-A2020-10-02
00827002037953KopansG03795DKBL-20-11.0-A2020-10-02
00827002042933KopansG04293DKBL-20-15.0-U2020-10-02
00827002042964KopansG04296DKBL-20-9.0-A-U2020-10-02
00827002043435KopansG04343DKBL-20-5.0-A-U2020-10-02
00827002053465KopansG05346DKBL-21-11.0-A2020-10-02
00827002058620KopansG05862DKBL-21-5.0-A-U2020-10-02
00827002073708KopansG07370DKBL-21-9.0-A-U2020-10-02
00827002090422KopansG09042DKBL-21-7.0-A-U2020-10-02
00827002099845KopansG09984DKBL-20-7.0-A-U2020-10-02
00827002099852KopansG09985DKBL-20-15.0-A-U2020-10-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00853277008084LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy)UVISION 360, INC.FCK2021-08-13
00853277008091LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy)UVISION 360, INC.FCK2021-08-13
B194HP10001rbi2 suction rectal biopsy systemAUS SYSTEMS PTY. LIMITED.FCK2016-10-24
B194SS10001rbi2 suction rectal biopsy system AUS SYSTEMS PTY. LIMITED.FCK2016-10-24
09340254000632TREWAVIS SURGICALTREWAVIS SURGICAL INSTRUMENTS PTY LTDFCK2016-10-20
B194CP12001rbi2 suction rectal biopsy systemAUS SYSTEMS PTY. LIMITED.FCK2016-08-29
B194MR1001rbi2 suction rectal biopsy systemAUS SYSTEMS PTY. LIMITED.FCK2016-08-29
CP12000rbi2 suction rectal biopsy systemAUS SYSTEMS PTY. LIMITED.FCK2016-08-29
CP12001rbi2 suction rectal biopsy systemAUS SYSTEMS PTY. LIMITED.FCK2016-08-29
CP12002rbi2 suction rectal biopsy systemAUS SYSTEMS PTY. LIMITED.FCK2016-08-29