FDA.reportPublic FDA data

RP Medical

Primary DI
00850032955003
Brand
RP Medical
Company
RP Medical Inc
Model
39-1960-100
Device description
Pivot Sterilization Case
Published
2021-12-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K181845000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181845000Pivot System Sterilization caseRp Medical, Inc.2019-11-25KCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850032955003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850032955003008500329550038500329550030850032955003

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing clinical instruments (typically endoscopes or surgical instruments) for use during a clinical procedure; it might in addition be used during, but not dedicated to, reprocessing/sterilization procedures. It is typically in the form of a shallow vessel with a raised rim, a deeper cassette-like device, or a flat or angled surface; it might include a lid. It may be designed to fit into other devices such as supply trolleys, storage systems and sterilizers, or designed to attach to a surgical/treatment table where it may be placed over the patient. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
203732607
Device count
1
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
00850032955010RP Medical39.1960.10.012021-12-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00385640095341INSTRUSAFESummit Medical, Inc.KCT2026-10-28
00385640095358INSTRUSAFESummit Medical, Inc.KCT2026-10-28
00385640095365INSTRUSAFESummit Medical, Inc.KCT2026-10-28
07899995224002SURGICAL KIT VERSALISSin Sistema de Implante Nacional S/AKCT2026-10-28
G476ISTO20X10X2ISTO BIOLOGICS SteriZign Sterilization TraySterizign Precision Technologies, LLCKCT2026-10-27
00385640095327INSTRUSAFESummit Medical, Inc.KCT2026-10-26
00385640095334INSTRUSAFESummit Medical, Inc.KCT2026-10-26
03701045278962KONTACTBIOTECH DENTALKCT2026-10-26
03701045278979KONTACTBIOTECH DENTALKCT2026-10-26
06973993446022Sterilization CassetteAlliedstar Medical Equipment Co., Ltd.KCT2026-10-26
00385640095303INSTRUSAFESummit Medical, Inc.KCT2026-10-23
00385640095310INSTRUSAFESummit Medical, Inc.KCT2026-10-23
00642356006673Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006680Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006697Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006703Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006710Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006734Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006758Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006765Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006772Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006789Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006796Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006802Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006819Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006826Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006833Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006840Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006857Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006864Mastel SurgicalMastel Surgical Inc.KCT2026-10-23