FDA.reportPublic FDA data

V. Mueller

Primary DI
10885403130632
Brand
V. Mueller
Company
CAREFUSION 2200, INC
Model
SU21062
Catalog number
SU21062
Device description
V. Mueller FRANKLIN-SILVERMAN BIOPSY NDLE OUTER CANN LGTH 6" (15.2CM) CANNULA HUB LGTH 7-1/2" (19CM) SPLIT NDLE HUB 8-1/4" (21CM)
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FCGBiopsy needle

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCGBiopsy NeedleGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885403130632PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088540313063210885403130632

GMDN Terms#

Term, Definition table
TermDefinition
Body aspiration needle, reusableA 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 reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)323-9088gmb-MedSpec-CustService@carefusion.com
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
832696038
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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
18809327353412ClearTipFINEMEDIX CO.,LTD.FCG2026-03-24
18809327355539ClearTipFINEMEDIX CO.,LTD.FCG2026-03-24
18809327355546ClearTipFINEMEDIX CO.,LTD.FCG2026-03-24
18809327355553ClearTipFINEMEDIX CO.,LTD.FCG2026-03-24
18809327355560ClearTipFINEMEDIX CO.,LTD.FCG2026-03-24
18809327355577ClearTipFINEMEDIX CO.,LTD.FCG2026-03-24
18809327355966ClearTipFINEMEDIX CO.,LTD.FCG2026-03-24
18809327355973ClearTipFINEMEDIX CO.,LTD.FCG2026-03-24
18809327355980ClearTipFINEMEDIX CO.,LTD.FCG2026-03-24
18809327355997ClearTipFINEMEDIX CO.,LTD.FCG2026-03-24
18809327356000ClearTipFINEMEDIX CO.,LTD.FCG2026-03-24
18809327356017ClearTipFINEMEDIX CO.,LTD.FCG2026-03-24
18809327356024ClearTipFINEMEDIX CO.,LTD.FCG2026-03-24
18809327356031ClearTipFINEMEDIX CO.,LTD.FCG2026-03-24
18809327356048ClearTipFINEMEDIX CO.,LTD.FCG2026-03-24
18809327356055ClearTipFINEMEDIX CO.,LTD.FCG2026-03-24
18809327356062ClearTipFINEMEDIX CO.,LTD.FCG2026-03-24
18809327356079ClearTipFINEMEDIX CO.,LTD.FCG2026-03-24
18809327356086ClearTipFINEMEDIX CO.,LTD.FCG2026-03-24
20884450476127CorVocet™Merit Medical Systems, Inc.FCG2026-02-28
00860014682926PrecisionPoint Corbin Clinical Resources, LLCFCG2026-02-04
14953170459204Single-use Fine Needle Biopsy (FNB) Device NA-U210HOLYMPUS MEDICAL SYSTEMS CORP.FCG2025-12-02
14953170459259Single-use Fine Needle Biopsy (FNB) Device NA-U210HOLYMPUS MEDICAL SYSTEMS CORP.FCG2025-12-02
14953170459310Single-use Fine Needle Biopsy (FNB) Device NA-U210HOLYMPUS MEDICAL SYSTEMS CORP.FCG2025-12-02
04048223128480ChibaSonoPajunk GmbH MedizintechnologieFCG2025-07-30
08033003340806BIOMOLH.S. HOSPITAL SERVICE SPAFCG2025-07-07
08033055140300BIOMOLH.S. HOSPITAL SERVICE SPAFCG2025-07-07
04048223128268ChibaSonoPajunk GmbH MedizintechnologieFCG2025-06-17
04048223128275ChibaSonoPajunk GmbH MedizintechnologieFCG2025-06-17
04048223128336ChibaSonoPajunk GmbH MedizintechnologieFCG2025-06-17