FDA.reportPublic FDA data

CERAMENT™ BEAD TRAY

Primary DI
07350055430318
Brand
CERAMENT™ BEAD TRAY
Company
Bone Support AB
Model
A0513
Device description
A single use bead mold for molding beads out of ceramic bone graft substitutes. The bead mold consists of cavities in three different sizes. The cavities are filled with ceramic bone graft substitute and evenly distributed across the mold using the spatula. The ceramic bone graft substitute sets in the cavities and the ceramic bone graft substitute beads are then removed from the mold.
Published
2023-06-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350055430318PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350055430318073500554303187350055430318

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic bone graft bead mouldA device typically in the form of a tray with rows of rounded depressions of various sizes intended to mould synthetic (e.g., ceramic) bone grafts into beads (small spherical-like portions) for subsequent placement into a bone void. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
350066052
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350055430035CERAMENT™BONE VOID FILLER A0210-08A0210-082015-09-17
07350055430042CERAMENT™BONE VOID FILLER A0210-09A0210-092015-09-17
07350055430066CERAMENT™BONE VOID FILLER A0210-11A0210-112015-09-17
07350055430523CERAMENT® G A0535-052024-02-01
07350055430530CERAMENT® G A0535-062024-02-01
07350055430394CERAMENT® G A0450-112022-12-06
07350055430387CERAMENT® G A0450-102022-10-05

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