FDA.reportPublic FDA data

PLAT Tip Adapter Large

Primary DI
00858406007853
Brand
PLAT Tip Adapter Large
Company
Surgentec, LLC
Model
GG-NTA-08
Published
2025-03-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00858406007853PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858406007853008584060078538584060078530858406007853

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
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
004095409
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
00810131881061 BMAC Bevel Needle SR07-1500AAN-11-BMACS2025-01-03
00810131880941 BMAN Solid Diamond Needle SR07-1100AAN-09-BMANS2024-12-31
00810131880958 BMAN Solid Diamond Needle Kit SR07-1101AAN-09-BMAN2024-12-31
00810131880965BMAN Solid Diamond Needle - Two Pack SR07-1102AAN-09-2BMANS2024-12-31
00810131880972BMAN Solid Diamond Needle Kit - Two Pack SR07-1103AAN-09-2BMAN2024-12-31
00810131881009 BMAC Diamond Needle SR07-1300AAN-09-BMACS2024-12-31
00850040139587"SI Guidewire 9"""SR16-5001SI-P-GP2024-08-16
00810131880583 Mallet - Large - Large HeadSR99-60002024-12-10
00810131880590 Mallet - Large - Small HeadSR99-60012024-12-10
00810131880606"1/4"" Square Drill Chuck"SR99-60022024-12-10
00810131880729 Bone Chisel SR99-60032024-12-10
00858406007181OsteoFlo Synthetic NanoPutty Syringe- 1ccONP-S-012020-11-19
00858406007198OsteoFlo Synthetic NanoPutty Syringe- 2.5ccONP-S-022020-11-19
00858406007204OsteoFlo Synthetic NanoPutty Syringe- 510ccONP-S-102020-11-19
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05391530753944FD-1017NS - 1ml PC Syringe - White PlungerDMC MEDICAL LIMITEDFMF2026-06-03
05391530753951FD-1018NS - 1ml PC Syringe - Blue PlungerDMC MEDICAL LIMITEDFMF2026-06-03
05391530754217FD-1078NS 20ml PC Syringe - White Plunger - Saline PrintDMC MEDICAL LIMITEDFMF2026-06-03
05391530754620FD-1048NS 10ml PC Syringe Yellow Plunger LidocaineDMC MEDICAL LIMITEDFMF2026-06-03
05391530754699FD-1075NS 10ml PC Syringe Light Blue Plunger XylocaineDMC MEDICAL LIMITEDFMF2026-06-03
05391530754941FD-1180NS 3ml Nugen Syringe Red PlungeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754965FD-1162NS 10ml Nugen Syringe Red PlungerDMC MEDICAL LIMITEDFMF2026-06-03
05391530753968FD-1019NS - 1ml PC Syringe - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530754088FD-1021NS 3ml PC Syringe White PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530754194FD-1034NS 20ml PC Syringe Red PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530754224FD-1033NS 20ml PC Syringe - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530754231FD-1092NS 20ml PC Syringe Heparin Print - Red PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530753456FD-1032NS - 20ml PC Syringe Blue PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753463FD-1031NS - 20ml PC Syringe White PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753487FD-1113NS - 10ml PC Syringe Contrast Dark Green PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753517FD-1051NS - 10ml PC Syringe Purple Plunger - Lidocaine PrintDMC MEDICAL LIMITEDFMF2026-06-01
05391530753524FD-1043NS - 10ml PC Syringe - Contrast - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753531FD-1107NS - 30ml PC Syringe - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753548FD-1026NS - 10ml PC Syringe - White PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753555FD-1158NS - 10ml PC Syringe - Heparin/Saline White PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753562FD-1049NS - 10ml PC Syringe - Lidocaine Print - Red PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753579FD-1029NS - 10ml PC Syringe Red PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753593FD-1054NS - 10ml PC Syringe - Nitro Print - Red PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753609FD-1039NS - 10ml PC Syringe - Heparin Print - Red PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753616FD-1071NS - 10ml PC Syringe - Purple PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753623FD-1028NS - 10ml PC Syringe - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753647FD-1072NS - 10ml PC Syringe Dark Green PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753654FD-1030NS - 10ml PC Syringe - Light Green PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753661FD-1042NS - 10ml PC Syringe - Contrast Print - Light Blue PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753678FD-1044NS - 10ml PC Syringe - Contrast Print - Red PlungerDMC MEDICAL LIMITEDFMF2026-06-01