AccessGUDID - DEVICE: CERAMENT® G (07350055430394)

GUDID

Device Identifier (DI) Information

Brand Name: CERAMENT® G
Version or Model: A0450-11
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Bone Support AB

Primary DI Number: 07350055430394
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 350066052 *Terms of Use

Device Description: CERAMENT G is an implantable bone void filler (device/ drug combination product) indicated for use as an adjunct to systemic antibiotic therapy and surgical debridement (standard treatment approach to a bone infection) where there is a need for supplemental bone graft. CERAMENT G combines gentamicin sulfate with a bone void filler, consisting of hydroxyapatite and calcium sulfate. By eluting gentamicin, CERAMENT G can reduce the recurrence of chronic osteomyelitis from gentamicin-sensitive microorganisms in order to protect bone healing. By combining calcium sulfate and hydroxyapatite, a balance is achieved between implant resorption rate and bone remodeling rate. Calcium sulfate acts as a resorbable carrier for hydroxyapatite. Hydroxyapatite has a slow resorption rate and high osteoconductivity providing a scaffold for new bone generation. The use of CERAMENT G eliminates the need to harvest autologous bone, thereby avoiding donor site morbidity (e.g., pain, infection, etc.) in patients with a diagnosed infection. CERAMENT G may be implanted by an injectable system or inserted as pre-set beads.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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:	Yes
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?
47255	Bone matrix implant, synthetic, antimicrobial	A bioabsorbable device made of synthetic material implanted into the body to provide osteoconductive bone-tissue scaffolds to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis); it includes an antibiotic to inhibit bacterial growth. It is typically made of ceramics (e.g., tricalcium phosphate or hydroxyapatite), sometimes bioactive glasses or bioabsorbable polymers, and used to fill cystic defects, repair fractures, and/or extend autogenous bone grafts. It is typically provided as cancellous blocks, chips, or granules, or mouldable materials.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
QRR	Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN210044	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 15 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 5 Milliliter

Device Record Status

Public Device Record Key: 45594fbb-34eb-4227-8e8e-295372e24220
Public Version Date: December 14, 2022
Public Version Number: 1
DI Record Publish Date: December 06, 2022