7.5cc Graft Tube Pusher

Primary DI
00858406007082
Brand
7.5cc Graft Tube Pusher
Company
Surgentec, LLC
Model
GG-GTP-02
Published
2025-02-12
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
FMFSyringe, Piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170675000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170675000Graftgun Universal Graft Delivery SystemSurGenTec, LLC2017-07-19FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858406007082PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858406007082008584060070828584060070820858406007082

GMDN Terms#

Term, Definition table
TermDefinition
Syringe dose safety regulatorA non-powered device intended to be used by a healthcare provider to help safely administer a precise dose of medication from a (prefilled) syringe to a patient. It is in the form of a rod with volume graduations, secured alongside the syringe plunger, which includes a perpendicular sliding lock intended to mechanically obstruct the movement of the plunger into the syringe barrel beyond the desired volume mark, for safe medication administration. This is a single-use device.

Sterilization Methods#

Method table
Method

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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