FDA.report

ACHIEVE

Primary DI
50885403245136
Brand
ACHIEVE
Company
CAREFUSION 2200, INC
Model
BA1211
Catalog number
BA1211
Device description
BREAST ACHIEVE NEEDLE BIOPSY 12G X 11CM
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
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KNWINSTRUMENT, BIOPSY

Product Code Classifications

CodeDeviceSpecialtyClass
KNWInstrument, BiopsyGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50885403245136PackageGS15Not in Commercial Distribution
10885403245138PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5088540324513650885403245136
1088540324513810885403245138

GMDN Terms

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

TypeValueUnit
Length11Centimeter
Needle Gauge12Gauge

Sterilization Methods

Method

Contacts

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

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