FDA.reportPublic FDA data

CODMAN®

Primary DI
10381780521402
Brand
CODMAN®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
831325
Catalog number
83-1325
Device description
CODMAN® Peel-Away Catheter Introducer 12.5FR.
Published
2020-04-01
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
GYKInstrument, shunt system implantation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GYKInstrument, Shunt System ImplantationNeurology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K883607000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K883607000PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETERCodman & Shurtleff, Inc.1988-09-30GYK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780521402PrimaryGS10
00381780521405Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038178052140210381780521402
00381780521405003817805214053817805214050381780521405

GMDN Terms#

Term, Definition table
TermDefinition
Subcutaneous tunneller, single-useA 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 and is not a dedicated pacing or defibrillation lead tunneller. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge12.5French

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
081277700
Device count
10
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780024507Integra® Jarit®100539100-5392018-01-22
10381780024514Integra® Jarit®100540100-5402018-01-22
10381780031901Integra® Miltex®27-20227-2022015-09-22
10381780031918Integra® Miltex®27-20427-2042015-09-22
10381780031925Integra® Miltex®27-20627-2062015-09-22
10381780031932Integra® Miltex®27-20827-2082015-09-22
10381780031949Integra® Miltex®27-21027-2102015-09-22
10381780031956Integra® Miltex®27-21227-2122015-09-22
10381780063865Integra® Miltex®4-515C4-515C2018-02-15
10381780063872Integra® Miltex®4-5224-5222018-02-15
10381780063896Integra® Miltex®461146112018-02-15
10381780063902Integra® Miltex®461546152018-02-15
10381780064206Integra® Miltex®33-3833-382018-02-14
10381780128779Integra® Miltex®30-174030-17402016-08-03
10381780133810Integra® Jarit®320437320-4372016-08-12
10381780134503Integra® Jarit®6531016531012018-01-15
10381780136408Integra® Jarit®X37254X372542016-08-14
10381780142874Integra® Jarit®230250230-2502016-08-14
10381780143048Integra® Jarit®320195320-1952016-08-14
10381780143055Integra® Jarit®320196320-1962016-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10381780537397CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGYK2024-05-29
10381780537403CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGYK2024-05-29
10381780537410CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGYK2024-05-29
03760124131451SophysaSOPHYSAGYK2023-06-02
03760124131444SophysaSOPHYSAGYK2023-06-02
13760124131458SophysaSOPHYSAGYK2023-06-02
03760124131468SophysaSOPHYSAGYK2023-06-02
03760124131475SophysaSOPHYSAGYK2023-06-02
04041906505530AESCULAPAesculap AGGYK2023-04-03
04041906505547AESCULAPAesculap AGGYK2023-04-03
04041906505554AESCULAPAesculap AGGYK2023-04-03
04041906505561AESCULAPAesculap AGGYK2023-04-03
04041906505578AESCULAPAesculap AGGYK2023-04-03
04041906505585AESCULAPAesculap AGGYK2023-04-03
04041906505592AESCULAPAesculap AGGYK2023-04-03
04041906505608AESCULAPAesculap AGGYK2023-04-03
04041906507336AESCULAPAesculap AGGYK2023-04-03
04041906507343AESCULAPAesculap AGGYK2023-04-03
04041906507350AESCULAPAesculap AGGYK2023-04-03
04041906507367AESCULAPAesculap AGGYK2023-04-03
04041906507374AESCULAPAesculap AGGYK2023-04-03
04041906507381AESCULAPAesculap AGGYK2023-04-03
04041906507398AESCULAPAesculap AGGYK2023-04-03
04041906507404AESCULAPAesculap AGGYK2023-04-03
00763000031268N/AMEDTRONIC PS MEDICAL, INC.GYK2020-07-20
00382830057325Natus®NATUS MEDICAL INCORPORATEDGYK2020-04-17
00382830057332Natus®NATUS MEDICAL INCORPORATEDGYK2020-04-17
00382830058193Natus®NATUS MEDICAL INCORPORATEDGYK2020-04-17
00382830058186Natus®NATUS MEDICAL INCORPORATEDGYK2020-04-17
10885403070488V. MuellerCAREFUSION 2200, INCGYK2020-04-15