AccessGUDID - DEVICE: BoneFoam (B197925GULLYDRB0)

GUDID

Device Identifier (DI) Information

Brand Name: BoneFoam
Version or Model: 925.GULLYDRB
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 925.GULLYDRB
Company Name: BONE FOAM, INC.

Primary DI Number: B197925GULLYDRB0
Issuing Agency: HIBCC
Commercial Distribution End Date: September 13, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 079636174 *Terms of Use

Device Description: sterile bags

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:	Yes
Prescription Use (Rx):	No
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?
12535	Medical equipment drape, single-use	A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PUI	Drape, Surgical, Exempt

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: Yes
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: 232e2a42-cca6-4041-bfb6-ec5c0e595fc7
Public Version Date: April 11, 2023
Public Version Number: 4
DI Record Publish Date: October 10, 2016