AccessGUDID - DEVICE: Orbitum VI Staple (B565FO100120120)

GUDID

Device Identifier (DI) Information

Brand Name: Orbitum VI Staple
Version or Model: Rev A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FO-1001-2012
Company Name: CPM Medical Consultants, LLC

Primary DI Number: B565FO100120120
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 017138000 *Terms of Use

Device Description: 20mm Hourglass Staple

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?
61668	Orthopaedic bone staple, non-adjustable, non-sterile	A non-sterile, non-bioabsorbable, implantable device designed to be inserted into fractured bone to achieve fixation and repair; the device may also be used to attach/secure structures (e.g., ligaments/tendons) to bone, or to reduce/cease bone growth in skeletal deformities (e.g., by being implanted across epiphysial cartilage). It is typically a curved or U-shaped device made of metal alloy material, and is not adjustable after it has been applied. Disposable devices associated with implantation may be included.	Obsolete	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: 02e95588-35b2-4596-b107-e558f7a19424
Public Version Date: March 19, 2025
Public Version Number: 2
DI Record Publish Date: February 11, 2021