FDA.reportPublic FDA data

CODMAN

Primary DI
20886704000508
Brand
CODMAN
Company
CODMAN & SHURTLEFF, INC.
Model
16-1057
Catalog number
161057
Device description
CODMAN Disposable ICP LUER-LOK Connector
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K910938000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K910938000CODMAN EXTERNAL DRAINAGE SYSTEM II (EDS II)Codman & Shurtleff, Inc.1991-08-16JXG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20886704000508PackageGS13In Commercial Distribution
10886704000501PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088670400050820886704000508
1088670400050110886704000501

GMDN Terms#

Term, Definition table
TermDefinition
Cerebrospinal fluid catheter tubing setA two-way tubing with a stopcock designed to connect the proximal end of a cerebrospinal fluid (CSF) drainage catheter directly to a drainage bag or an intracranial pressure monitor via a Luer connection. It is typically made of polymer materials [e.g., polyvinyl chloride (PVC)] and profiled at both ends to create leak-proof connections. It may also feature a tap-like valve to isolate the line when injecting, flushing, or replacing the drainage bag. 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
20886704043826CODMANAP-09150AP091502014-09-20
20886704072888CODMANAP-04009AP040092014-09-20
20886704036675DURAFORM80-14728014722015-09-20
20886704036699DURAFORM80-14748014742015-09-20
20886704036712DURAFORM80-14768014762015-09-20
20886704036736DURAFORM80-14788014782015-09-20
20886704079429DURAFORM80-1472US801472US2016-03-22
20886704079443DURAFORM80-1474US801474US2016-03-22
20886704079467DURAFORM80-1476US801476US2016-03-22
20886704079481DURAFORM80-1478US801478US2016-03-22
20886704029172TRUFILL633-0006330002015-09-20
20886704029189TRUFILL633-0106330102015-09-20
20886704029219TRUFILL633-1206331202015-09-20
20886704029226TRUFILL633-1406331402015-09-20
20886704029233TRUFILL633-1606331602015-09-20
20886704029288TRUFILL633-3206333202015-09-20
20886704029301TRUFILL633-3306333302015-09-20
20886704029325TRUFILL633-3406333402015-09-20
20886704029349TRUFILL633-3506333502015-09-20
20886704029363TRUFILL633-3606333602015-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10381780535881CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535928CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535942CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535393CODMAN® CERTAS® PlusIntegra LifeSciences Switzerland SàrlJXG2024-11-20
10381780535430CODMAN® CERTAS® PlusIntegra LifeSciences Switzerland SàrlJXG2024-11-20
10381780535829CODMAN® CERTAS® PlusIntegra LifeSciences Switzerland SàrlJXG2024-11-20
10381780535867CODMAN® CERTAS® PlusIntegra LifeSciences Switzerland SàrlJXG2024-11-20
10381780536734CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-05-29
10381780536741CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-05-29
10381780536758CODMAN® ACCU-FLO®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-05-29
10381780536765CODMAN® ACCU-FLO®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-05-29
10381780536789CODMAN® ACCU-FLO®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-05-29
10381780536819CODMAN® ACCU-FLO®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-05-29