AccessGUDID - DEVICE: Regatta (10889981329969)

GUDID

Device Identifier (DI) Information

Brand Name: Regatta
Version or Model: RP3-209300
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RP3-209300
Company Name: Seaspine Orthopedics Corporation

Primary DI Number: 10889981329969
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079840876 *Terms of Use

Device Description: Lateral Fixation Pin Caddy

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:	No
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?
12143	Instrument tray, reusable	A container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MAX	Intervertebral fusion device with bone graft, lumbar
OVD	Intervertebral fusion device with integrated fixation, lumbar
PHM	Intervertebral fusion device with bone graft, thoracic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K240566	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d4aa21f9-178e-4715-9587-429780a1f7da
Public Version Date: January 27, 2025
Public Version Number: 1
DI Record Publish Date: January 17, 2025