FDA.reportPublic FDA data

TSI

Primary DI
00843059115529
Brand
TSI
Company
TEDAN SURGICAL INNOVATIONS, L.L.C.
Model
ML-1140
Device description
SCRAPER RASP
Published
2017-08-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HTRRasp

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTRRaspGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00843059115529PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843059115529008430591155298430591155290843059115529

GMDN Terms#

Term, Definition table
TermDefinition
Bone file/rasp, manualA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
791619393
Device count
1
Premarket exempt
true
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
00843059126945MedtronicMDT-0442S2026-04-28
00843059126969MedtronicMDT-0459S2026-04-28
00843059126990MedtronicMDT-0469S2026-04-28
008430591217353CorD-00122018-08-09
008430591217593CorD-00162018-08-09
00843059121797LDR Spine USA0022LDR2018-08-09
00843059121803LDR Spine USA0024LDR2018-08-09
00843059125979TSIUL-0360SUL-0360S-052022-07-15
00843059125986TSIUL-0362SUL-0362S-052022-07-15
00843059125993TSIUL-0364SUL-0364S-052022-07-15
00843059126006TSIUL-0366SUL-0366S-052022-07-15
00843059126013TSIUL-0368SUL-0368S-052022-07-15
00843059126020TSIUL-0370SUL-0370S-052022-07-15
00843059126037TSIUL-0372SUL-0372S-052022-07-15
00843059126044TSIUL-0374SUL-0374S-052022-07-15
00843059126051TSIUL-0376SUL-0376S-052022-07-15
00843059126068TSIUL-0378SUL-0378S-052022-07-15
00851797006443TSIDS-00122017-05-22
00851797006450TSIDS-00142017-05-22
00851797006467TSIDS-00162017-05-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08806395408917PulsarGS Medical Co., Ltd.HTR2022-11-01
08806395408924PulsarGS Medical Co., Ltd.HTR2022-11-01
08806395408931PulsarGS Medical Co., Ltd.HTR2022-11-01
08806395408948PulsarGS Medical Co., Ltd.HTR2022-11-01
08806395408955PulsarGS Medical Co., Ltd.HTR2022-11-01
08806395408962PulsarGS Medical Co., Ltd.HTR2022-11-01
08806395408979PulsarGS Medical Co., Ltd.HTR2022-11-01
08806395408986PulsarGS Medical Co., Ltd.HTR2022-11-01
08806395408993PulsarGS Medical Co., Ltd.HTR2022-11-01
08806395409006PulsarGS Medical Co., Ltd.HTR2022-11-01
10381780503231Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTR2020-10-01
10381780507888Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTR2018-09-12
10381780393016Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTR2018-05-02
10381780280859Integra® Spider™ Limted Wrist Fusion SystemAscension Orthopedics, Inc.HTR2018-04-13
10381780280866Integra® Spider™ Limted Wrist Fusion SystemAscension Orthopedics, Inc.HTR2018-04-13
10381780467076Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTR2018-04-09
10381780467083Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTR2018-04-09
10381780467090Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTR2018-04-09
10381780189329Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTR2018-04-03
10381780192800Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTR2018-04-03
10381780192817Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTR2018-04-02
10381780192824Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTR2018-04-02
10381780192831Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTR2018-04-02
10381780192848Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTR2018-04-02
10381780192855Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTR2018-04-02
10381780192862Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTR2018-04-02
10381780193012Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTR2018-04-02
10381780461616Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTR2018-03-22
10381780212188Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTR2018-03-01
10381780212195Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTR2018-03-01