AccessGUDID - DEVICE: ENDOBON® (03599870091272)

GUDID

Device Identifier (DI) Information

Brand Name: ENDOBON®
Version or Model: ROX20
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIOMET 3I, LLC

Primary DI Number: 03599870091272
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 186127825 *Terms of Use

Device Description: ENDOBON® XENOGRAFT GRANULES 2.0ML

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?
48097	Bone matrix implant, animal-derived, non-bioabsorbable	A sterile non-bioabsorbable device made primarily of animal-derived bone matrix (e.g., heat-treated hydroxyapatite ceramic from animal cancellous bone) implanted into the body to provide osteoconductive bone-tissue scaffolds to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis). It is used to fill bone cavities, defects, and fractures, and contains pores that promote the ingrowths of endogenous bone for skeletal reconstruction or augmentation. It is typically provided as cancellous blocks, cylinders, or granules.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LYC	Bone grafting material, synthetic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 2 Milliliter
Device Size Text, specify: Particle Size 1 mm
Device Size Text, specify: Particle Size 0.5 mm

Device Record Status

Public Device Record Key: de760c7e-c085-4a78-b6ec-b96560ee1167
Public Version Date: March 10, 2022
Public Version Number: 3
DI Record Publish Date: September 10, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)342-5454
Email: 3iPBG-CS@biomet.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES