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
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07640462720332NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07640462720660NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07640462720677NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07640462720684NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07630031782298Straumann Modular CassetteInstitut Straumann AGKCT2026-05-07
10197344177806MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344177813MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344177820MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178117MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
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10197344178629MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
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10197344177783MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-15
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10197344177950MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-15
10197344177967MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-15