AccessGUDID - DEVICE: AccuPort Side Delivery Cannula 11 Ga x 120mm (00889024406438)

GUDID

Device Identifier (DI) Information

Brand Name: AccuPort Side Delivery Cannula 11 Ga x 120mm
Version or Model: 303.250
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 303.250
Company Name: ZIMMER KNEE CREATIONS, INC.

Primary DI Number: 00889024406438
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078836317 *Terms of Use

Device Description: No description.

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?
47997	Bone grafting cannula	A rigid tube intended to be used surgically to introduce a bone void filler (e.g., a bone matrix implant/bone substitute) in voids or gaps of the skeletal system (i.e., extremities, craniofacial bone, spine, and pelvis) to fill defects in the bone structure created surgically or traumatically. It is typically made of metal materials (e.g., high-grade stainless steel) with or without a plastic hub at the distal end to connect to a syringe or other device that propels the filler. The device may also be used for the delivery of orthopaedic cement. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FGY	Cannula, Injection

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 120 Millimeter
Needle Gauge: 11 Gauge

Device Record Status

Public Device Record Key: d18a15f4-6096-4602-8b60-ef7dd83a2c1d
Public Version Date: May 26, 2023
Public Version Number: 4
DI Record Publish Date: May 18, 2016