FDA.reportPublic FDA data

Puros®

Primary DI
00889024406339
Brand
Puros®
Company
ZIMMER SPINE, INC.
Model
84038005
Published
2015-11-24
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
MBPFiller, Bone Void, Osteoinduction (W/O Human Growth Factor)
MQVFiller, Bone Void, Calcium Compound

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBPFiller, Bone Void, Osteoinduction (W/O Human Growth Factor)Orthopedic2
MQVFiller, Bone Void, Calcium CompoundOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024406339PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024406339008890244063398890244063390889024406339

GMDN Terms#

Term, Definition table
TermDefinition
Bone matrix implant, human-derivedAn sterile implantable device made primarily of human demineralized bone matrix (DBM) (acid extraction of allogeneic bone resulting in loss of most of the mineralized component but retention of proteins) intended to fill bony voids or gaps caused by trauma or surgery, including use in the maxillofacial and/or mandibular bone. The device is bioabsorbable, osteoconductive, and has demonstrated at least potential osteoinductivity for the stimulation of new bone growth. The DBM may be combined with various carrier compounds (e.g., gelatin, hydrogel, starch) or other materials. It is available in the form of powder, crushed granules, putty, chips, or a gel that can be injected through a syringe.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume5Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
787663400
Device count
1
HCT/P
true
Lot or batch
true
Serial number
true
Expiration date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024399006SlimLine®403-4072403-40722015-09-25
00889024403741SlimLine®403-4068403-40682019-12-02
00889024403758SlimLine®403-4076403-40762019-12-02
00889024403765SlimLine®403-4080403-40802019-12-02
00889024403772SlimLine®403-4084403-40842019-12-02
00889024403789SlimLine®403-4088403-40882019-12-02
00889024403796SlimLine®403-4092403-40922019-12-02
00889024404083SlimLine®403-4168403-41682019-12-02
00889024404090SlimLine®403-4172403-41722019-12-02
00889024404106SlimLine®403-4176403-41762019-12-02
00889024404113SlimLine®403-4180403-41802019-12-02
00889024404120SlimLine®403-4184403-41842019-12-02
00889024404137SlimLine®403-4188403-41882019-12-02
00889024404144SlimLine®403-4192403-41922019-12-02
00889024404151SlimLine®404-2036404-20362019-11-17
00889024404168SlimLine®404-2040404-20402019-11-17
00889024404175SlimLine®404-2042404-20422019-11-17
00889024404182SlimLine®404-2044404-20442019-11-17
00889024404199SlimLine®404-2046404-20462019-11-17
00889024404205SlimLine®404-2048404-20482019-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08719699710122MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710276MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710283MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710290MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710306MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710313MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710320MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710337MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710344MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710351MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710368MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710375MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710382MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710399MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710405MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710412MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710436MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710443MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710450MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710429MagnetOsKuros Biosciences B.V.MQV2018-01-05
08809204338580TruForm+Hans Biomed Corp.MQV2017-07-18
08809204338580TruForm+Hans Biomed Corp.MBP2017-07-18
08809204338597TruForm+Hans Biomed Corp.MQV2017-07-18
08809204338597TruForm+Hans Biomed Corp.MBP2017-07-18
08809204338603TruForm+Hans Biomed Corp.MQV2017-07-18
08809204338603TruForm+Hans Biomed Corp.MBP2017-07-18
08809204338610TruForm+Hans Biomed Corp.MQV2017-07-18
08809204338610TruForm+Hans Biomed Corp.MBP2017-07-18
08809204338627TruForm+Hans Biomed Corp.MQV2017-07-18
08809204338627TruForm+Hans Biomed Corp.MBP2017-07-18