AccessGUDID - DEVICE: Osteoamp Flowable Access Cannula (00816986020525)

GUDID

Device Identifier (DI) Information

Brand Name: Osteoamp Flowable Access Cannula
Version or Model: OFAC-C
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OFAC-C
Company Name: BIOVENTUS LLC

Primary DI Number: 00816986020525
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078450878 *Terms of Use

Device Description: The Allograft Delivery Device consists of a cannula and push rod made of biocompatible polypropylene. The device is provided sterile and is intended to be used with hydrated allograft to facilitate delivery into bony defects in orthopedic surgical sites.

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?
47997	Bone grafting cannula	A rigid tube intended to be used surgically to introduce a bone void filler (e.g., a bone matrix implant/bone substitute) in voids or gaps of the skeletal system (i.e., extremities, craniofacial bone, spine, and pelvis) to fill defects in the bone structure created surgically or traumatically. It is typically made of metal materials (e.g., high-grade stainless steel) with or without a plastic hub at the distal end to connect to a syringe or other device that propels the filler. The device may also be used for the delivery of orthopaedic cement. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMF	Syringe, Piston

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K233368	000

Device Exempt from Premarket Submission: No 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
Storage Environment Temperature: between 11 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d1009662-473f-44bb-b380-9fc817bb425d
Public Version Date: November 29, 2024
Public Version Number: 1
DI Record Publish Date: November 21, 2024