OsteoFlo Synthetic NanoPutty Syringe- 510cc

Primary DI
00858406007204
Brand
OsteoFlo Synthetic NanoPutty Syringe- 510cc
Company
Surgentec, LLC
Model
ONP-S-10
Published
2020-11-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200064000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200064000OsteoFlo NanoPutty-Quadphasic Synthetic Bone GraftSurGenTec, LLC2020-08-14MQV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858406007204PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858406007204008584060072048584060072040858406007204

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.

Regulatory Flags#

DUNS number
004095409
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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00810131880583 Mallet - Large - Large HeadSR99-60002024-12-10
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00810131880606"1/4"" Square Drill Chuck"SR99-60022024-12-10
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00858406007181OsteoFlo Synthetic NanoPutty Syringe- 1ccONP-S-012020-11-19
00858406007198OsteoFlo Synthetic NanoPutty Syringe- 2.5ccONP-S-022020-11-19
00858406007211OsteoFlo Synthetic NanoPutty Syringe- 5ccONP-S-052020-11-19
00858406007228OsteoFlo Synthetic NanoPutty Cartridge- 5ccONP-T-5002020-11-18
00858406007235OsteoFlo Synthetic NanoPutty Cartridge- 10ccONP-T-10002020-11-19
00081013188039 ION AO Coupling Cannulated Handle SR12-50062026-03-09
00810131880330"T-Handle 3/16"" Connection"SR11-50022026-03-09
00810131881252 6.5/7.0 Drill Bit SR12-64422026-03-09
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