FDA.reportPublic FDA data

Graftgun® Universal (GDS™) Graft Delivery System- Additional 5cc Graftgun Tube

Primary DI
00858406007136
Brand
Graftgun® Universal (GDS™) Graft Delivery System- Additional 5cc Graftgun Tube
Company
Surgentec, LLC
Model
GG-T-01
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
00858406007136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858406007136008584060071368584060071360858406007136

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810131880736OsteoFlo Synthetic HydroPutty HFP - 1ccOHFP-S-012025-06-10
00810131880743OsteoFlo Synthetic HydroPutty HFP - 3ccOHFP-S-032025-06-10
00810131880750OsteoFlo Synthetic HydroPutty HFP - 6ccOHFP-S-062025-06-10
00810131880767OsteoFlo Synthetic HydroPutty HFP - 12ccOHFP-S-122025-06-10
00810131881139OsteoFlo Synthetic Nanoputty Syringe - 5cc - IOSALONP-S-05 - IB2025-06-10
00810131881146OsteoFlo Synthetic Nanoputty Syringe - 10cc - IOSALONP-S-10 - IB2025-06-10
00810131881153OsteoFlo Synthetic Nanoputty Cartridge - 10cc - IOSALONP-T-1000-IB2025-06-10
00810131881160OsteoFlo Synthetic Nanoputty Cartridge - 10cc - IOSALONP-T-1000-IB2025-06-10
00810131881177OsteoFlo HydroPutty Synthetic HFP - 6cc Labeled - IOSALOHFP-S-06-IB2025-06-10
00810131881184OsteoFlo HydroPutty Synthetic HFP - 12cc Labeled - IOSALOHFP-S-12-IB2025-06-10
00858406007648OsteoFlo Synthetic Nanoputty Cartridge Graftgun Combo Kit - 5ccONP-K-5002025-06-10
00858406007655OsteoFlo Synthetic Nanoputty Cartridge Graftgun Combo Kit - 10ccONP-K-10002025-06-10
00858406007662OsteoFlo Synthetic Nanoputty Syringe Graftgun Combo Kit - 1ccONP-U-012025-06-10
00858406007679OsteoFlo Synthetic Nanoputty Syringe Graftgun Combo Kit - 2.5ccONP-U-022025-06-10
00858406007686OsteoFlo Synthetic Nanoputty Syringe Graftgun Combo Kit - 5ccONP-U-052025-06-10
00858406007693OsteoFlo Synthetic Nanoputty Syringe Graftgun Combo Kit - 10ccONP-U-102025-06-10
00810131880545Global Tip Adapter - LongGG-NTA-122025-03-14
00810131881191Global Tip Adapter - NarrowGG-NTA-142025-03-14
00810131881207Bullet Global Tip AdapterGG-NTA-132025-03-14
00858406007150Bullet Tip AdapterGG-NTA-032025-03-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06934841531291TKMDAnhui Tiankang Medical Technology Co., Ltd.FMF2026-10-23
MHC182332552EasyTouchMHC MEDICAL PRODUCTS, LLCFMF2026-10-21
09347144013062Metier MedicalMETIER MEDICAL LTDFMF2026-10-19
09347144013123Metier MedicalMETIER MEDICAL LTDFMF2026-10-19
09347144015004Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
09347144016186Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
09347144016216Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
20612479288496McKessonMCKESSON MEDICAL-SURGICAL INC.FMF2026-10-08
20612479288526McKessonMCKESSON MEDICAL-SURGICAL INC.FMF2026-10-08
10304040193843Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040193850Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040193867Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040193874Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040193881Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040193898Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194109Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194116Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194208Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194215Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
00850091070532CoreCareCorecare Products Inc.FMF2026-09-11
00850091070556CoreCareCorecare Products Inc.FMF2026-09-11
00850091070570CoreCareCorecare Products Inc.FMF2026-09-11
00850091070594CoreCareCorecare Products Inc.FMF2026-09-11
00850091070617CoreCareCorecare Products Inc.FMF2026-09-11
00850091070631CoreCareCorecare Products Inc.FMF2026-09-11
00850091070655CoreCareCorecare Products Inc.FMF2026-09-11
00850091070679CoreCareCorecare Products Inc.FMF2026-09-11
10816336022671NC603500-ENFNEOCHILD, LLCFMF2026-09-10
00850091070242CoreCareCorecare Products Inc.FMF2026-09-04
00850091070372CoreCareCorecare Products Inc.FMF2026-09-04