FDA.reportPublic FDA data

ACHIEVE

Primary DI
50885403238077
Brand
ACHIEVE
Company
CAREFUSION 2200, INC
Model
BCA1411
Catalog number
BCA1411
Device description
ACHIEVE Coaxial Programmable Automatic Biopsy System 14GX11CM
Published
2017-12-21
Public version status
Update
Distribution status
Not 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
KNWINSTRUMENT, BIOPSY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNWInstrument, BiopsyGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885403238077PackageGS15Not in Commercial Distribution
10885403238079PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088540323807750885403238077
1088540323807910885403238079

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue biopsy procedure kit, non-medicatedA collection of sterile devices designed to perform a non-specific soft tissue biopsy. It includes the biopsy needle used for this procedure; it does not include a pharmaceutical. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length11Centimeter
Needle Gauge14Gauge

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)323-9088gmb-MedSpec-CustService@carefusion.com

Regulatory Flags#

DUNS number
832696038
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
50382909101206Surgiphor9101209101202026-03-05
10885403273780PleurX50-007550-00752017-06-12
10885403075964PleurX50-905050-90502017-06-12
50885403075993Denver42-200042-20002017-06-12
50885403076006Denver42-205542-20552017-06-12
50885403076082Denver42-205042-20502017-06-12
10885403051722V. MuellerHY21305HY213052017-08-11
10885403049408V. MuellerGU4050-008GU4050-0082018-08-30
10885403071263V. MuellerNL1350NL13502018-09-05
10885403105159V. MuellerOS5000-002OS5000-0022018-09-10
20885403473170N/A5513E5513E2019-03-25
50885403142176Wet Exidine448944892018-07-18
50885403142183NA442044202018-07-18
50885403142190NA4461A4461A2018-07-18
50885403142220NA4472A4472A2018-07-18
50885403175211NA443744372018-07-18
50885403184473NA446844682018-07-18
50885403184480NA4469A4469A2018-07-18
50885403192829Scrub Care ExidineCLEAN1CLEAN12018-05-02
10885403465154Snowden-PencerSI325SI3252018-01-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974405095210CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.KNW2026-05-26
06974405095227CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.KNW2026-05-26
06974405095067CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.KNW2026-05-25
00841911100508Mammotome PrimaDEVICOR MEDICAL PRODUCTS, INC.KNW2026-03-13
00841911102281Mammotome PrimaDEVICOR MEDICAL PRODUCTS, INC.KNW2026-03-13
00841911102458Mammotome PrimaDEVICOR MEDICAL PRODUCTS, INC.KNW2026-03-13
00841911102489Mammotome PrimaDEVICOR MEDICAL PRODUCTS, INC.KNW2026-03-13
00841911102496Mammotome PrimaDEVICOR MEDICAL PRODUCTS, INC.KNW2026-03-13
00841911102632Mammotome PrimaDEVICOR MEDICAL PRODUCTS, INC.KNW2026-03-13
00801741234187EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-02-09
10801741234153EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-02-04
10801741234160EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-02-04
00801741236167EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-02-04
00801741234194EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-02-03
00801741234248EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-02-03
00801741234262EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-02-03
00801741235221EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-02-03
10801741234092EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-01-30
10801741234139EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-01-30
00801741234200EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-01-30
10801741234115EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-01-28
10801741234146EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-01-28
10801741234177EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-01-28
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10850075308047HYDRACELL-EXT-5RANFAC CORP.KNW2025-09-25
10850075308061HYDRACELL-EXT-10RANFAC CORP.KNW2025-09-25
08058983746639TRAP EASYH.S. HOSPITAL SERVICE SPAKNW2025-09-23
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10810563022732OmniBone Bone Biopsy Kit with 11 Gauge 108mm lengthVARIAN MEDICAL SYSTEMS, INC.KNW2025-09-18