FDA.report

V. Mueller

Primary DI
10885403103131
Brand
V. Mueller
Company
CAREFUSION 2200, INC
Model
SU130-1111
Catalog number
SU130-1111
Device description
V. Mueller RAYPORT MUSCLE BIOPSY CLAMP JAW 10MMWIDE
Published
2018-09-17
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

Related Records

Contact Domains

Product Codes

CodeName
FCLFORCEPS, BIOPSY, NON-ELECTRIC

Product Code Classifications

CodeDeviceSpecialtyClass
FCLForceps, Biopsy, Non-ElectricGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10885403103131PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088540310313110885403103131

GMDN Terms

TermDefinition
Muscle biopsy clampA sterile manual gripping device designed to secure muscle tissue in order to obtain a biopsy sample. It is used to hold a muscle fibre specimen in a longitudinal position to help preserve the original orientation of the fibres, from the sampling stage through analysis of the tissue. It will typically be designed so that, with the in situ sample, it can fit into an automated histological processing/analysing machine. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)323-9088Customer_Support@BD.com
+1(800)548-4873xx@xx.xx

Regulatory Flags

DUNS number
832696038
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
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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20885403473170N/A5513E5513E2019-03-25
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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

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