N/A

Primary DI
50885403108561
Brand
N/A
Company
CAREFUSION 2200, INC
Model
4380
Catalog number
4380
Device description
Economy Soft Tissue Biopsy Tray
Published
2018-07-18
Public version status
Update
Distribution status
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
FSHTray, surgical, needle

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSHTray, Surgical, NeedleGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885403108561PackageGS110In Commercial Distribution
10885403108563PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088540310856150885403108561
1088540310856310885403108563

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue biopsy procedure kit, medicatedA collection of sterile devices, which includes a pharmaceutical(s), designed to perform a non-specific soft tissue biopsy (e.g., skin biopsy, breast biopsy); it is not dedicated to biopsy of a specific internal organ. It includes the biopsy needle used for this procedure. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)321-4254Customer_Support@BD.com

Regulatory Flags#

DUNS number
832696038
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
true
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885403057229JamshidiBAK4508BAK45082016-09-23
10885403057236JamshidiBAK4511BAK45112016-09-23
10885403057267JamshidiBEK4511BEK45112016-09-30
10885403075971PleurX50-7000B50-7000B2017-09-15
10885403076022Denver42-301942-30192017-06-12
10885403076046Denver42-900042-90002017-06-12
10885403107702JamshidiBCTM3411SPBCTM3411SP2016-09-30
10885403108365Safe-T-CentesisPIG1260TPIG1260T2018-07-18
10885403108389Safe-T-CentesisPIG1260TSPPIG1260TSP2018-07-18
10885403108402Safe-T-CentesisPIG1280TPIG1280T2018-07-18
10885403108426Safe-T-CentesisPIG1280TSPPIG1280TSP2018-07-18
10885403108433Safe-TTPT1000SPTPT1000SP2018-07-18
10885403108488NATPT1000TPT10002018-07-18
10885403108495Safe-TTPT1000SDFTPT1000SDF2018-07-18
10885403220852NATPT1005TPT10052018-07-18
10885403220869Safe-TTPT1005SPTPT1005SP2018-07-18
10885403228131Safe-TTPT1005SDFTPT1005SDF2018-07-18
10885403231780JamshidiBAK4511DFBAK4511DF2016-09-23
10885403231896Safe-T-CentesisPIG1260TCDFPIG1260TCDF2018-07-18
10885403231902NATPT1000CDFTPT1000CDF2018-07-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10603295538806INHANCEDEPUY (IRELAND)FSH2026-05-01
10603295564102INHANCEDEPUY (IRELAND)FSH2026-05-01
10603295559696INHANCE INTACTDEPUY (IRELAND)FSH2025-06-13
10889942691678Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FSH2018-08-28
10889942746507Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FSH2018-08-28
10885403108563N/ACAREFUSION 2200, INCFSH2018-07-18
10885403247224N/ACAREFUSION 2200, INCFSH2018-07-18
50885403247222N/ACAREFUSION 2200, INCFSH2018-07-18
10885403057243JamshidiCAREFUSION 2200, INCFSH2016-09-30
10885403057267JamshidiCAREFUSION 2200, INCFSH2016-09-30
10885403076152JAMSHIDICAREFUSION 2200, INCFSH2016-09-30
10885403076169JAMSHIDICAREFUSION 2200, INCFSH2016-09-30
10885403076176JAMSHIDICAREFUSION 2200, INCFSH2016-09-30
10885403076190JAMSHIDICAREFUSION 2200, INCFSH2016-09-30
10885403076206JAMSHIDICAREFUSION 2200, INCFSH2016-09-30
10885403076213JAMSHIDICAREFUSION 2200, INCFSH2016-09-30
10885403103186JamshidiCAREFUSION 2200, INCFSH2016-09-30
10885403108594JamshidiCAREFUSION 2200, INCFSH2016-09-30
10885403108600JamshidiCAREFUSION 2200, INCFSH2016-09-30
10885403108624JamshidiCAREFUSION 2200, INCFSH2016-09-30
10885403108662JamshidiCAREFUSION 2200, INCFSH2016-09-30
10885403108686JamshidiCAREFUSION 2200, INCFSH2016-09-30
10885403108693JamshidiCAREFUSION 2200, INCFSH2016-09-30
50885403076150JAMSHIDICAREFUSION 2200, INCFSH2016-09-30
50885403076167JAMSHIDICAREFUSION 2200, INCFSH2016-09-30
50885403076174JAMSHIDICAREFUSION 2200, INCFSH2016-09-30
50885403076198JAMSHIDICAREFUSION 2200, INCFSH2016-09-30
50885403076204JAMSHIDICAREFUSION 2200, INCFSH2016-09-30
50885403076211JAMSHIDICAREFUSION 2200, INCFSH2016-09-30
50885403108592JamshidiCAREFUSION 2200, INCFSH2016-09-30