FDA.reportPublic FDA data

InQu

Primary DI
00865179000028
Brand
InQu
Company
ISTO TECHNOLOGIES INC
Model
IN006
Catalog number
IQSP-MX-150
Device description
5x10cm Matrix
Published
2015-09-01
Public version status
Update
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
MQVFiller, Bone Void, Calcium Compound

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQVFiller, Bone Void, Calcium CompoundOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00865179000028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00865179000028008651790000288651790000280865179000028

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic bone graftAn artificial bone substitute used for structural bone replacement typically when bone is lost due to disease (e.g., osteoporosis) or injury. It consists mainly of porous and mesh ceramic materials that provide a framework for bone growth, or harvested sea coral that serves as an additive, extender, or provides a framework for bone growth. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius27 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
035854152
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00865179000004InQuIN001IQSP-GR-1302015-09-01
00865179000011InQuIN002IQSP-GR-1102015-09-01
00865179000035InQuIN007IQSP-MX-1252015-09-01
00865179000042InQuIN008IQSP-PP-1102015-09-01
00865179000059InQuIN009IQSP-PP-1052015-09-01
00865179000066InQuIN010IQSP-PP-1022015-09-01
00865179000073InQuIN012IQSP-PP-1012015-09-01

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