FDA.reportPublic FDA data

RP Medical

Primary DI
00850032955256
Brand
RP Medical
Company
RP Medical Inc
Model
39.1960.10.03 SU
Device description
Pivot Osteotome straight long
Published
2023-05-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
00850032955256PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850032955256008500329552568500329552560850032955256

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic osteotome blade, single-useA 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 single-use 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
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
00850032955010RP Medical39.1960.10.012021-12-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776432102MillenniumAvalign Technologies, Inc.GFI2026-09-22
04054462912070evonosevonos GmbH & Co. KGGFI2026-08-19
04054462912094evonosevonos GmbH & Co. KGGFI2026-08-19
04054462912216evonosevonos GmbH & Co. KGGFI2026-08-19
04054462912223evonosevonos GmbH & Co. KGGFI2026-08-19
04054462912254evonosevonos GmbH & Co. KGGFI2026-08-19
04054462912261evonosevonos GmbH & Co. KGGFI2026-08-19
04054462912421evonosevonos GmbH & Co. KGGFI2026-08-19
04054462912520evonosevonos GmbH & Co. KGGFI2026-08-19
04054462912940evonosevonos GmbH & Co. KGGFI2026-08-19
04054462912957evonosevonos GmbH & Co. KGGFI2026-08-19
04054462900305evonosevonos GmbH & Co. KGGFI2026-08-18
04054462900312evonosevonos GmbH & Co. KGGFI2026-08-18
04054462900329evonosevonos GmbH & Co. KGGFI2026-08-18
04054462900336evonosevonos GmbH & Co. KGGFI2026-08-18
04054462900343evonosevonos GmbH & Co. KGGFI2026-08-18
04054462900350evonosevonos GmbH & Co. KGGFI2026-08-18
04054462900367evonosevonos GmbH & Co. KGGFI2026-08-18
04054462912087evonosevonos GmbH & Co. KGGFI2026-08-18
04054462912100evonosevonos GmbH & Co. KGGFI2026-08-18
04054462912131evonosevonos GmbH & Co. KGGFI2026-08-18
04054462912148evonosevonos GmbH & Co. KGGFI2026-08-18
00841435123717TecometTECOMET INC.GFI2026-07-30
00841435123724TecometTECOMET INC.GFI2026-07-30
00841435123731TecometTECOMET INC.GFI2026-07-30
00190776395384MillenniumAvalign Technologies, Inc.GFI2026-07-13
00841435123557TecometTECOMET INC.GFI2025-02-07
00841435123564TecometTECOMET INC.GFI2025-02-07
00841435123571TecometTECOMET INC.GFI2025-02-07
00841435121355TecometTECOMET INC.GFI2023-07-21