InFill Graft Delivery System

Primary DI
00814729026155
Brand
InFill Graft Delivery System
Company
PINNACLE SPINE GROUP, LLC
Model
99-0500
Published
2016-08-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143488000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143488000InFill Graft Delivery SystemPinnacle Spine Group, LLC2014-12-17FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814729026155PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814729026155008147290261558147290261550814729026155

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic cement dispenserA syringe-like device intended for use in placing orthopaedic bone cement into surgical sites. Cement dispensers may be manually-operated or mounted in a powered unit that drives the piston down the syringe barrel. This is a single-use device.

Sterilization Methods#

Method table
Method
"[""Radiation Sterilization"", ""Moist Heat or Steam Sterilization""]"
Radiation Sterilization;Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
962347980
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814729020009InFill V2 Lateral PEV2-00-183008-PE2016-08-26
00814729020016InFill V2 Lateral PEV2-00-183010-PE2016-08-26
00814729020023InFill V2 Lateral PEV2-00-183012-PE2016-08-26
00814729020030InFill V2 Lateral PEV2-00-183014-PE2016-08-26
00814729020047InFill V2 Lateral PEV2-07-183008-PE2016-08-26
00814729020054InFill V2 Lateral PEV2-07-183010-PE2016-08-26
00814729020061InFill V2 Lateral PEV2-07-183012-PE2016-08-26
00814729020078InFill V2 Lateral PEV2-07-183014-PE2016-08-26
00814729020085InFill V2 Lateral PEV2-10-183008-PE2016-08-26
00814729020092InFill V2 Lateral PEV2-10-183010-PE2016-08-26
00814729020108InFill V2 Lateral PEV2-10-183012-PE2016-08-26
00814729020115InFill V2 Lateral PEV2-10-183014-PE2016-08-26
00814729020122InFill V2 Lateral PEV2-13-183010-PE2016-08-26
00814729020139InFill V2 Lateral PEV2-13-183012-PE2016-08-26
00814729020146InFill V2 Lateral PEV2-13-183014-PE2016-08-26
00814729020153InFill V2 Lateral PEV2-00-183508-PE2016-08-26
00814729020160InFill V2 Lateral PEV2-00-183510-PE2016-08-26
00814729020177InFill V2 Lateral PEV2-00-183512-PE2016-08-26
00814729020184InFill V2 Lateral PEV2-00-183514-PE2016-08-26
00814729020191InFill V2 Lateral PEV2-07-183508-PE2016-08-26

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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20612479288526McKessonMCKESSON MEDICAL-SURGICAL INC.FMF2026-10-08
10304040193843Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040193850Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
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10304040193881Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040193898Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
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10304040194307Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194314Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
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