AccessGUDID - DEVICE: SCP® Foot & Ankle Kit (00889024205345)

GUDID

Device Identifier (DI) Information

Brand Name: SCP® Foot & Ankle Kit
Version or Model: 514.303
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: ZIMMER KNEE CREATIONS, INC.

Primary DI Number: 00889024205345
Issuing Agency: GS1
Commercial Distribution End Date: October 22, 2024
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:	Yes
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?
46119	Bone graft delivery kit	A collection of sterile devices intended to be used to prepare and/or deliver bone graft material during an orthopaedic surgical procedure. It typically includes aspirating/delivery/mixing syringe(s), an adaptor, and a needle/cannula. It allows for the aspiration and/or premixing of bone marrow, autologous blood, plasma, intravenous fluids (IVF), and bone void filler (e.g., allograft, autograft, synthetic bone graft material), and their delivery to the surgical site. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

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: Store at 15-25: (59-77;)
Handling Environment Temperature: between 59 and 77 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4192c1d0-512a-4e22-9692-2bf50d1cbe3d
Public Version Date: January 16, 2025
Public Version Number: 4
DI Record Publish Date: October 23, 2015