FDA.reportPublic FDA data

RP Medical

Primary DI
00850032955065
Brand
RP Medical
Company
RP Medical Inc
Model
39.1960.20.03
Device description
Pivot Osteotome angled straight long
Published
2021-12-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GFIOsteotome, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFIOsteotome, ManualGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850032955065PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850032955065008500329550658500329550650850032955065

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic osteotome blade, reusableA sharp component of an orthopaedic osteotome intended to be attached to a dedicated handle (not included) to become a chisel-like surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. It is typically flat or curved (concave) in design and bevelled on one or both sides; it is made of high-grade stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
203732607
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
00850032955201RP Medical500-012021-12-31
00850032955218RP Medical500-01-042021-12-31
00850032955225RP Medical39.1960.70.01 SU2023-05-10
00850032955232RP Medical39.1960.70.02 SU2023-05-10
00850032955249RP Medical39.1960.70.03 SU2023-05-10
00850032955256RP Medical39.1960.10.03 SU2023-05-10
00850032955263RP Medical39.1960.10.04 SU2023-05-10
00850032955270RP Medical39.1960.10.02 SU2023-05-10
00850032955287RP Medical39.1960.10.01 SU2023-05-10
00850032955294RP Medical39.1960.30.02 SU2023-05-10
00850032955300RP Medical39.1960.30.03 SU2023-05-10
00850032955317RP Medical39.1960.51.01 SU2023-05-10
00850032955324RP Medical39.1960.51.02 SU2023-05-10
00850032955331RP Medical39.1960.52.01 SU2023-05-10
00850032955348RP Medical39.1960.52.02 SU2023-05-10
00850032955355RP Medical39.1960.20.02 SU2023-05-10
00850032955362RP Medical39.1960.20.03 SU2023-05-10
00850032955379RP Medical39.1960.60.02 SU2023-05-10
00850032955386RP Medical39.1960.022023-05-10
00850032955003RP Medical39-1960-1002021-12-31

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