FDA.reportPublic FDA data

KIT SURGICAL EPIKUT PTG

Primary DI
07899995250667
Brand
KIT SURGICAL EPIKUT PTG
Company
Sin Sistema de Implante Nacional S/A
Model
KCSEP 01
Catalog number
KCSEP 01
Device description
KIT SURGICAL EPIKUT PTG
Published
2024-07-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241378000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241378000S.I.N. Instrument KitsS.I.N. - Sistema DE Implante Nacional S.A.2024-07-12KCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07899995250667PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07899995250667078999952506677899995250667

GMDN Terms#

Term, Definition table
TermDefinition
Dental/maxillofacial surgical procedure kit, non-medicated, reusableA collection of various dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
904569092
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07899995243898FIXATION SCREW CM11.5° ANG. MOD BPFCM 01BPFCM 01B2026-07-22
07899995243904FIXATION SCREW CM11.5° ANG. MOD APFCM 01APFCM 01A2026-07-22
07899995243928PARAF. DE FIXACAO MT16° ANG. MOD BPFMT 01BPFMT 01B2026-07-22
07899995243935PARAF. DE FIXACAO MT16° ANG. MOD APFMT 01APFMT 01A2026-07-22
07899995235299DRIVER HANDPIECE MINI ABUT. EXT. LONGCTA 01ELCTA 01EL2026-07-14
07899995235305DRIVER HANDPIECE MINI ABUT. LONGCTA 01LCTA 01L2026-07-14
07899995235312DRIVER HANDPIECE MINI ABUT. MEDIUMCTA 01MCTA 01M2026-07-14
07899995235329DRIVER RATCHET ABUT. HEX 2MM EXT. LONGCCA 01ELCCA 01EL2026-07-14
07899995235343DRIVER RATCHET ABUT. HEX 2MM LONGCCA 01LCCA 01L2026-07-14
07899995235367DRIVER RATCHET ABUT. HEX 2MM MEDIUMCCA 01MCCA 01M2026-07-14
07899995235374DRIVER RATCHET ABUT. HEX 2MM SHORTCCA 01CCCA 01C2026-07-14
07899995235381DRIVER RATCHET ABUT. HEX 2MM EXT. SHORTCCA 01ECCCA 01EC2026-07-14
07899995235503DRIVER RATCHET RETRIVER M1.6MM LONGCCER 18LCCER 18L2026-07-14
07899995235510DRIVER RATCHET RETRIVER M1.8MM MEDIUMCCER 18MCCER 18M2026-07-14
07899995235527DRIVER RATCHET RETRIVER M1.8MM SHORTCCER 18CCCER 18C2026-07-14
07899995235534DRIVER RATCHET RETRIVER M1.6MM LONGCCER 16LCCER 16L2026-07-14
07899995235565DRIVER RATCHET RETRIVER M1.6MM SHORTCCER 16CCCER 16C2026-07-14
07899995235541RATCHET RETRIEVER DRIVER M1.6 MEDIUMCCER 16MCCER 16M2026-06-23
07899995279668Abutment ScrewPRH 30 PACK4PRH 30 PACK42026-03-13
07899995243805DRIVER RATCHET HEX1.4 EXT. LONG ANG.CCH 1437ACCH 1437A2025-12-23

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Primary DI, Brand, Company table
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