AccessGUDID - DEVICE: Jamshidi (10885403108594)

GUDID

Device Identifier (DI) Information

Brand Name: Jamshidi
Version or Model: SK1015A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SK1015A
Company Name: CAREFUSION 2200, INC

Primary DI Number: 10885403108594
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 832696038 *Terms of Use

Device Description: Jamshidi Menghini Soft Tissue Biopsy Tray - 15 G x 100 mm Needle/Syringe with Centimeter Depth Markings

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
16835	Soft-tissue biopsy procedure kit, non-medicated	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FSH	Tray, surgical, needle

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 20 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Needle Gauge: 15 Gauge
Length: 100 Millimeter

Device Record Status

Public Device Record Key: 9457e6bd-74e6-48fa-aa80-917200e7a6be
Public Version Date: August 01, 2023
Public Version Number: 4
DI Record Publish Date: September 30, 2016