FDA.report

Cook

Primary DI
00827002128163
Brand
Cook
Company
COOK INCORPORATED
Model
G12816
Catalog number
DCHN-25-5.0-U
Device description
Chiba Biopsy Needle
Published
2020-10-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
MJGDEVICE, PERCUTANEOUS, BIOPSY

Product Code Classifications

CodeDeviceSpecialtyClass
MJGDevice, Percutaneous, BiopsyGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00827002128163PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002128163008270021281638270021281630827002128163

GMDN Terms

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

TypeLowHighCondition
Special Storage Condition, Specify00Store in dark, dry, cool place.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(812)330-5494sharedservices@cookmedical.com

Regulatory Flags

DUNS number
042823948
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
true
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 DIBrandModelCatalogPublished
00827002613508SureTome SWG61350SUR-SW-352025-12-08
10827002613512SureTome SWG61351SUR-SW-AWG2-35-2602025-12-08
10827002613529SureTome SWG61352SUR-SW-AWG2-35-4502025-12-08
10827002242378BakriG24237J-SOSR-1005002016-09-24
10827002306735BakriG30673J-SOS-1005002016-09-24
00827002607842COOKG60784TESLA-B2535-2602025-07-22
00827002607859COOKG60785TESLA-B2535-4502025-07-22
10827002597508COOKG59750TESLA-B-ACU2025-07-11
10827002496535Cotton-Leung Sof-FlexG49653CLSO-SF-10-52015-11-03
00827002352674HerculesG35267HBDE-W-8-9-102022-12-20
00827002352681HerculesG35268HBDE-W-10-11-122022-12-20
00827002352698HerculesG35269HBDE-W-12-13.5-152022-12-20
00827002352704HerculesG35270HBDE-W-15-16.5-182022-12-20
00827002352711HerculesG35271HBDE-W-18-19-202022-12-20
10827002346014FusionG34601FS-OMNI-ACRO-35-2052016-09-24
10827002346939FusionG34693FS-OMNI-ACRO-35-2602016-09-24
10827002347110FusionG34711FS-OMNI-ACRO-35-4502016-09-24
10827002347783D.A.S.H.G34778DASH-ACRO-35-4502016-09-24
10827002347790D.A.S.H.G34779DASH-ACRO-25-4502016-09-24
10827002347806D.A.S.H.G34780DASH-ACRO-35-2602016-09-24

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
50198956384000CARDINAL HEALTHCardinal Health 200, LLCMJG2026-03-19
50198956353556CARDINAL HEALTHCardinal Health 200, LLCMJG2026-03-10
50198956281132CARDINAL HEALTHCardinal Health 200, LLCMJG2026-02-17
50198956313222CARDINAL HEALTHCardinal Health 200, LLCMJG2026-01-30
50198956317923CARDINAL HEALTHCardinal Health 200, LLCMJG2026-01-30
50198956290929CARDINAL HEALTHCardinal Health 200, LLCMJG2026-01-23
50198956239157CARDINAL HEALTHCardinal Health 200, LLCMJG2025-12-26
50198956217247CARDINAL HEALTHCardinal Health 200, LLCMJG2025-12-23
50198956295085CARDINAL HEALTHCardinal Health 200, LLCMJG2025-12-19
50198956233445CARDINAL HEALTHCardinal Health 200, LLCMJG2025-12-11
50198956256048CARDINAL HEALTHCardinal Health 200, LLCMJG2025-11-28
50198956268348CARDINAL HEALTHCardinal Health 200, LLCMJG2025-11-28
50198956201147CARDINAL HEALTHCardinal Health 200, LLCMJG2025-11-25
50198956221695CARDINAL HEALTHCardinal Health 200, LLCMJG2025-11-11
50198956140958CARDINAL HEALTHCardinal Health 200, LLCMJG2025-09-29
50198956133592CARDINAL HEALTHCardinal Health 200, LLCMJG2025-08-28
04048223128954PrimoCutPajunk GmbH MedizintechnologieMJG2025-07-30
50198956127553CARDINAL HEALTHCardinal Health 200, LLCMJG2025-07-15
04048223128893PrimoCutPajunk GmbH MedizintechnologieMJG2025-06-17
04048223128947Coaxial sleeve Ø 1,50 (17G)Pajunk GmbH MedizintechnologieMJG2025-06-17
04048223131923Coaxial sleeve Ø 1,50 (17G)Pajunk GmbH MedizintechnologieMJG2025-06-17
50198956116564CARDINAL HEALTHCardinal Health 200, LLCMJG2025-06-16
50198956084092CARDINAL HEALTHCardinal Health 200, LLCMJG2025-06-11
50197106926800CARDINAL HEALTHCardinal Health 200, LLCMJG2025-06-10
50197106927999CARDINAL HEALTHCardinal Health 200, LLCMJG2025-06-10
50198956017533CARDINAL HEALTHCardinal Health 200, LLCMJG2025-06-05
50198956033540CARDINAL HEALTHCardinal Health 200, LLCMJG2025-06-05
50198956015720CARDINAL HEALTHCardinal Health 200, LLCMJG2025-05-09
50198956010107CARDINAL HEALTHCardinal Health 200, LLCMJG2025-04-17
50198956040340CARDINAL HEALTHCardinal Health 200, LLCMJG2025-04-09