FDA.reportPublic FDA data

CODMAN

Primary DI
20886704040405
Brand
CODMAN
Company
CODMAN & SHURTLEFF, INC.
Model
82-1515
Catalog number
821515
Device description
CODMAN Disposable Catheter Passer 36cm
Published
2015-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20886704040405PackageGS16In Commercial Distribution
30886704040402PackageGS16Not in Commercial Distribution
10886704040408PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088670404040520886704040405
3088670404040230886704040402
1088670404040810886704040408

GMDN Terms#

Term, Definition table
TermDefinition
Subcutaneous tunneller, single-useA sterile, hand-held manual surgical instrument designed to create a subcutaneous tunnel (artificial passageway) between percutaneous entry and exit incisions for the subcutaneous placement of a device (e.g., catheter for medication administration, shunt). It is available in a variety of forms and may be: 1) a luminal sheath with a removable inner obturator, intended for co-axial device introduction, followed by sheath removal; or 2) a non-luminal device intended to either lead or pull the device through subcutaneous tissue. It is not intended for tunnelling through deep tissues. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
607846297
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886704085355CEREGLIDENIC71115UNIC71115U2023-07-07
10886704085386CEREGLIDENIC71137UNIC71137U2023-07-07
10886704085409CEREGLIDENIC71132UNIC71132U2023-07-07
10886704085423CEREGLIDENIC71125UNIC71125U2023-07-07
10886704078630CODMAN MALIS CMC801788R801788R2016-06-30
10886704046912CODMAN HAKIM RICKHAMNS5068NS50682015-09-20
10886704045366CODMAN HAKIM SIPHONGUARDNS0372NS03722015-09-20
10886704015505CRANIOPLASTIC43-12804312802015-09-20
10886704034995CODMAN FLEX170028700282014-09-20
10886704044598CODMAN HAKIM RICKHAMNS0147NS01472015-09-22
10886704064923MEDSTREAM91-4200US91-4200US2014-09-20
10886704064930MEDSTREAM91-4201US91-4201US2014-09-20
10886704029663TRUFILL DCS ORBIT637HF0204637HF02042015-09-20
10886704043591CODMANAP-03000HAP03000H2014-09-20
10886704043607CODMANAP-03000LAP03000L2014-09-20
10886704043614CODMANAP-03000MAP03000M2014-09-20
10886704043621CODMANAP-03000ULAP03000UL2014-09-20
20886704043826CODMANAP-09150AP091502014-09-20
20886704072888CODMANAP-04009AP040092014-09-20
10886704038689CODMAN80-29078029072016-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000422646StrataMR2MEDTRONIC PS MEDICAL, INC.JXG2026-03-13
00763000422684StrataMR2MEDTRONIC PS MEDICAL, INC.JXG2026-03-13
03760409446294Phoenix NeuroSOPHYSAJXG2025-12-24
B775EVACMRI0PHASORPHASOR HEALTH LLCJXG2025-11-24
10381780521051CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535386CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535409CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535416CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535423CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535904CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535966CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535980CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780536000CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780536024CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780536048CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780536062CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780536086CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780536109CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
B775EVAC0PHASORPHASOR HEALTH LLCJXG2025-06-04
04041906505622XABOChristoph Miethke GmbH & Co. KGJXG2025-05-31
04041906505639XABOChristoph Miethke GmbH & Co. KGJXG2025-05-31
04041906505646XABOChristoph Miethke GmbH & Co. KGJXG2025-05-31
04041906506667XABOChristoph Miethke GmbH & Co. KGJXG2025-05-31
04041906506674XABOChristoph Miethke GmbH & Co. KGJXG2025-05-31
04041906506681XABOChristoph Miethke GmbH & Co. KGJXG2025-05-31
04041906506698XABOChristoph Miethke GmbH & Co. KGJXG2025-05-31
04041906506704XABOChristoph Miethke GmbH & Co. KGJXG2025-05-31
04041906506711XABOChristoph Miethke GmbH & Co. KGJXG2025-05-31
04041906506728XABOChristoph Miethke GmbH & Co. KGJXG2025-05-31
04041906506735XABOChristoph Miethke GmbH & Co. KGJXG2025-05-31