FDA.reportPublic FDA data

Delta®

Primary DI
00763000028367
Brand
Delta®
Company
MEDTRONIC PS MEDICAL, INC.
Model
42813
Device description
VALVE 42813 DELTA SMALL LEVEL 1.5
Published
2020-01-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JXGShunt, central nervous system and components

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JXGShunt, Central Nervous System And ComponentsNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K902783000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K902783000PS MEDICAL DELTA CSF-FLOW CONTROL VALVEPudenz-Schulte Medical Research Corp.1990-08-08JXG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000028367PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000028367007630000283677630000283670763000028367

GMDN Terms#

Term, Definition table
TermDefinition
Ventriculo-peritoneal/atrial shunt valveA sterile implantable device intended to function as part of a ventriculoperitoneal or ventriculoatrial shunt to regulate the pressure and flow level of cerebrospinal fluid (CSF) from the brain to the peritoneum/heart right atrium in the management of increased intracranial pressure (e.g., caused by hydrocephalus). It consists of a mechanical valve with catheter connections and is made of plastic and silicone materials. It typically opens at a pre-set pressure and may be non-invasively adjusted using a dedicated programmer.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
089055867
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20763000467382NA464402024-02-26
00763000406080NA273022024-02-26
00763000624798Duet®469162022-03-10
00763000624804Duet®469172022-03-10
00763000406028Duet®469172021-02-07
00763000396008Duet®469152021-01-24
00763000343149N/A200342020-04-20
00763000029449N/A8023 B2020-03-07
00763000030827N/A250772020-03-08
00643169483316NA8023 B2015-06-24
00643169498365NA250772015-07-14
00643169507517NA8023 A2015-06-25
00643169073623NA250772015-06-25
00643169466142N/A461412015-07-15
00673978228969NA464222015-06-18
00673978246017NA272972015-07-21
00673978246031NA273022015-07-14
20643169466122N/A464402015-07-15
00763000422646StrataMR246955MR2026-03-13
00763000422684StrataMR246957MR2026-03-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03760409440285SophysaSOPHYSAJXG2026-06-22
03760409440308SophysaSOPHYSAJXG2026-06-22
03760409440315SophysaSOPHYSAJXG2026-06-22
03760409440322SophysaSOPHYSAJXG2026-06-22
03760409441121SophysaSOPHYSAJXG2026-06-05
03760409441138SophysaSOPHYSAJXG2026-06-05
03760409441145SophysaSOPHYSAJXG2026-06-05
03760409441152SophysaSOPHYSAJXG2026-06-05
03760409441169SophysaSOPHYSAJXG2026-06-05
03760409441176SophysaSOPHYSAJXG2026-06-05
03760409441183SophysaSOPHYSAJXG2026-06-05
03760409441190SophysaSOPHYSAJXG2026-06-05
03760409441206SophysaSOPHYSAJXG2026-06-05
03760409441213SophysaSOPHYSAJXG2026-06-05
03760409441220SophysaSOPHYSAJXG2026-06-05
03760409441237SophysaSOPHYSAJXG2026-06-05
03760409441244SophysaSOPHYSAJXG2026-06-05
03760409441251SophysaSOPHYSAJXG2026-06-05
03760409441268SophysaSOPHYSAJXG2026-06-05
10381780535362CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535379CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535393CODMAN® CERTAS® PlusIntegra LifeSciences Switzerland SàrlJXG2024-11-20
10381780535430CODMAN® CERTAS® PlusIntegra LifeSciences Switzerland SàrlJXG2024-11-20
20763000467382NAMEDTRONIC PS MEDICAL, INC.JXG2024-02-26
00763000406080NAMEDTRONIC PS MEDICAL, INC.JXG2024-02-26
10381780533900CODMAN® HAKIM®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2023-07-13
10381780534006CODMAN® HAKIM®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2023-07-13
10381780534013CODMAN® HAKIM®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2023-07-13
10381780534020CODMAN® HAKIM®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2023-07-13
10381780534037CODMAN® HAKIM®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2023-07-13