AccessGUDID - DEVICE: BoneFoam (00810075280890)

GUDID

Device Identifier (DI) Information

Brand Name: BoneFoam
Version or Model: 925.HIPPY
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 925.HIPPY
Company Name: BONE FOAM, INC.

Primary DI Number: 00810075280890
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079636174 *Terms of Use

Device Description: Direct Anterior Hip Positioning System (includes Direct Anterior Hip Positioning System Torso Base, two Direct Anterior Hip Positioning System Removeable Hip Bolsters, Direct Anterior Hip Positioning System Leg Board, two Direct Anterior Hip Positioning System Padded Peg Board Posts Large and two Direct Anterior Hip Positioning System Padded Peg Board Posts Small)

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":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
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?
65180	Operating table patient positioning set, reusable	A collection of devices intended to support and stabilize in a desired position a patient, or their body parts, on an operating table during a medical procedure (e.g., bariatric surgery, orthopaedic surgery, endotracheal tube intubation); some types may be intended to prevent a patient from sliding while in the Trendelenburg position or when applying traction. The set consists of multiple items which include two or more of the following: a base plate/bar that serves as a foundation to which patient positioners are attached, clamps/adaptors, and disposable/reusable padded positioners dedicated to a body part (e.g., non-slip positioning pad, headrest). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CCX	SUPPORT, PATIENT POSITION

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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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: 790ecd30-2c13-4bad-9161-8ba32b0fb13a
Public Version Date: May 10, 2024
Public Version Number: 4
DI Record Publish Date: May 22, 2022