FDA UDI In Commercial Distribution 🇺🇸 United States

Jamshidi

DI: 10885403108662 · Model: SK7015A · CAREFUSION 2200, INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Jamshidi
Primary DI
10885403108662
Version / Model
SK7015A
Catalog Number
SK7015A
Company Name
CAREFUSION 2200, INC
Labeler DUNS
832696038
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-30
Public Version
4
Public Version Date
2023-08-01
Public Version Status
Update
Public Device Record Key
ad024983-a237-4a7c-863a-3ad8a27494bf

Device Description

Jamshidi Menghini Soft Tissue Biopsy Tray - 15 G x 70 mm Needle/Syringe with Centimeter Depth Markings

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
Yes
Combination Product
Yes
HCT/P
No
Contains NRL
No
Not Made with NRL
Yes
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
FSH Tray, surgical, needle

GMDN Terms

Code Name
16835 Soft-tissue biopsy procedure kit, non-medicated

Identifiers

Type ID
Package 50885403108660
Primary 10885403108662

Customer Contacts

Device Sizes

Type Value Unit Text
Length 70 Millimeter
Needle Gauge 15 Gauge

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
20 – 25 Degrees Celsius