FDA.reportPublic FDA data

SABER-C RASP

Primary DI
00810017913428
Brand
SABER-C RASP
Company
ELEVATION SPINE, INC.
Model
CI-RASP4765
Catalog number
CI-RASP4765
Device description
Saber-C Rasp, 14x17x5, 6 deg
Published
2024-01-19
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
00810017913428PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810017913428008100179134288100179134280810017913428

GMDN Terms#

Term, Definition table
TermDefinition
Bone file/rasp, manual, reusableA 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
085718404
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
0081001791165312 (w) X 15 (d) Saber-C Cervical PlateCP-2568CP-25682019-12-20
0081001791166012 (w) X 15 (d) Saber-C Cervical PlateCP-2569CP-25692019-12-20
0081001791167712 (w) X 15 (d) Saber-C Cervical PlateCP-2561CP-25612019-12-20
0081001791168412 (w) X 15 (d) Saber-C Cervical PlateCP-2595CP-25952019-12-20
0081001791169112 (w) X 15 (d) Saber-C Cervical PlateCP-2596CP-25962019-12-20
0081001791170712 (w) X 15 (d) Saber-C Cervical PlateCP-2597CP-25972019-12-20
0081001791171412 (w) X 15 (d) Saber-C Cervical PlateCP-2598CP-25982019-12-20
0081001791172112 (w) X 15 (d) Saber-C Cervical PlateCP-2599CP-25992019-12-20
0081001791173812 (w) X 15 (d) Saber-C Cervical PlateCP-2591CP-25912019-12-20
0081001791174514 (w) X 15 (d) Saber-C Cervical PlateCP-4505CP-45052019-12-20
0081001791175214 (w) X 15 (d) Saber-C Cervical PlateCP-4506CP-45062019-12-20
0081001791176914 (w) X 15 (d) Saber-C Cervical PlateCP-4507CP-45072019-12-20
0081001791177614 (w) X 15 (d) Saber-C Cervical PlateCP-4508CP-45082019-12-20
0081001791178314 (w) X 15 (d) Saber-C Cervical PlateCP-4509CP-45092019-12-20
0081001791179014 (w) X 15 (d) Saber-C Cervical PlateCP-4501CP-45012019-12-27
0081001791180614 (w) X 15 (d) Saber-C Cervical PlateCP-4565CP-45652019-12-27
0081001791181314 (w) X 15 (d) Saber-C Cervical PlateCP-4566CP-45662019-12-27
0081001791182014 (w) X 15 (d) Saber-C Cervical PlateCP-4567CP-45672019-12-27
0081001791183714 (w) X 15 (d) Saber-C Cervical PlateCP-4568CP-45682019-12-27
0081001791184414 (w) X 15 (d) Saber-C Cervical PlateCP-4569CP-45692019-12-27

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
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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
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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