AccessGUDID - DEVICE: Orbitum Staple System (B565FO2002120)

GUDID

Device Identifier (DI) Information

Brand Name: Orbitum Staple System
Version or Model: Rev A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FO-2002-12
Company Name: CPM Medical Consultants, LLC

Primary DI Number: B565FO2002120
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 017138000 *Terms of Use

Device Description: 12mm Inserter

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?
10458	Orthopaedic bone staple driver	A hand-held surgical instrument designed to impart force on a bone staple, or on another instrument, to insert the bone staple typically into fractured bone. The distal end is typically shaped to mate with the bone staple. The proximal end is designed to absorb and transmit an impact force. It is typically made of high-grade stainless steel or titanium (Ti). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JDR	Staple, Fixation, Bone

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K173693	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: 2b372765-1ac4-4bec-ae22-437c4211fea9
Public Version Date: March 19, 2025
Public Version Number: 2
DI Record Publish Date: April 16, 2021