AccessGUDID - DEVICE: OnPoint Reusable Instrument Kit #2 (00850051682201)

GUDID

Device Identifier (DI) Information

Brand Name: OnPoint Reusable Instrument Kit #2
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TK0210201
Company Name: OnPoint Surgical, Inc.

Primary DI Number: 00850051682201
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080659059 *Terms of Use

Device Description: OnPoint Reusable Instrument Kit #2 with 2 Fixed Adapters, 2 Rotating Adapters, and 2 Power Adapters

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:	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?
45200	Orthopaedic stereotactic surgery system	An assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during orthopaedic surgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
SBF	Orthopedic Augmented Reality

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: 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: 61b180af-6d16-4587-80b7-dcaf504a3bfb
Public Version Date: October 14, 2024
Public Version Number: 1
DI Record Publish Date: October 04, 2024