FDA.report

MIS 4BONE

Primary DI
07290108991376
Brand
MIS 4BONE
Company
MIS Implants Technologies Ltd.
Model
4B-X2525
Device description
MIS 4Bone XBM Anorganic Bovine Bone Matrix
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
NPMBone Grafting Material, Animal Source

Product Code Classifications

CodeDeviceSpecialtyClass
NPMBone Grafting Material, Animal SourceDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07290108991376PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07290108991376072901089913767290108991376

GMDN Terms

TermDefinition
Dental bone matrix implant, animal-derivedA sterile bioabsorbable device made primarily of animal-derived bone or dentin matrix (e.g., bovine, porcine) implanted into the body to provide osteoconductive bone-tissue scaffolds to replace maxillofacial and/or mandibular bone lost through trauma or dental surgery. It is used to fill bone cavities and defects and contains pores that promote the ingrowth of endogenous bone for skeletal reconstruction and/or augmentation. It is typically provided as sterile cancellous blocks, chips, or granules of varying sizes, or mouldable materials.

Sterilization Methods

Method

Regulatory Flags

DUNS number
514576057
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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07290118505068MIS kitMG-KT082026-01-20
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07290118505938MIS C1C1-X083752026-01-20
07290118505945MIS C1C1C-X083752026-01-20
07290118505952MIS C1C1-X103752026-01-20
07290118505969MIS C1C1C-X103752026-01-20
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07290118505983MIS C1C1C-X113752026-01-20
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07290118506003MIS C1C1C-X133752026-01-20
07290118506010MIS C1C1-X163752026-01-20
07290118506027MIS C1C1C-X163752026-01-20
07290118506034MIS C1C1-X103302026-01-20

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