AccessGUDID - DEVICE: Monoject (10884521020443)

GUDID

Device Identifier (DI) Information

Brand Name: Monoject
Version or Model: SC4511
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SC4511
Company Name: Cardinal Health, Inc.

Primary DI Number: 10884521020443
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080935429 *Terms of Use

Device Description: Bone Marrow Biopsy and Aspiration Tray with Safety Components,16 G I-Type Sternal-Iliac Needle and 11 G Snarecoil Bone Marrow Needle

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":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
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?
16833	Bone marrow biopsy procedure kit	A packaged collection of sterile equipment that includes a disposable biopsy needle and other supplies used to perform a histologic specimen aspiration during a bone marrow biopsy. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GAA	NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
Special Storage Condition, Specify: ;

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Needle Gauge,16 (I-Type) and 11 (Bone Marrow Biopsy),Gauge;

Device Record Status

Public Device Record Key: d7240795-668b-4668-8977-d53b232078a9
Public Version Date: February 15, 2019
Public Version Number: 2
DI Record Publish Date: June 30, 2018