FDA.report

CODMAN

Primary DI
10381780514701
Brand
CODMAN
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
80-1180
Catalog number
801180
Device description
CODMAN Subarachnoid Screw
Published
2020-02-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HBGDRILLS, BURRS, TREPHINES & ACCESSORIES (MANUAL)

Product Code Classifications

CodeDeviceSpecialtyClass
HBGDrills, Burrs, Trephines & Accessories (Manual)Neurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10886704035947PreviousGS10
10381780514701PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088670403594710886704035947
1038178051470110381780514701

GMDN Terms

TermDefinition
Intracerebral sensor catheterA sterile flexible tube with a sensor at the distal end intended to be surgically inserted through the skull for short-term (= 30 days) access to the ventricular and/or parenchymal areas of the brain to drain cerebrospinal fluid (CSF) and to measure intracranial parameters [e.g., intracranial pressure (ICP), temperature, partial pressure of oxygen (pO2)]; it may also be intended for infusion of materials (e.g., chemotherapeutic agents, radioisotopes). It may include accessory devices intended to facilitate catheter introduction, stabilization, and/or fluid collection/infusion (e.g., stylet, bolts, drills, drainage/infusion port/reservoir). This is a single-use device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags

DUNS number
081277700
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10381780544319Codman® CereLink®826820P826820P2025-03-12
10381780524106CODMAN® BACTISEAL®NS0344NS03442024-11-20
10381780525370CODMAN® BACTISEAL®NS5091NS50912024-11-20
10381780521280CODMAN® CERTAS® Plus828807PL82-8807PL2024-11-20
10381780535805CODMAN® CERTAS® Plus828813PL82-8813PL2024-11-20
10381780535843CODMAN® CERTAS® Plus828823PL82-8823PL2024-11-20
10381780535867CODMAN® CERTAS® Plus828827PL82-8827PL2024-11-20
10381780536970CODMAN® BACTISEAL®82174582-17452024-11-20
10381780536987CODMAN® BACTISEAL®82307282-30722024-11-20
10381780536994CODMAN® BACTISEAL®82307382-30732024-11-20
10381780537007CODMAN® BACTISEAL®82307482-30742024-11-20
10381780537014CODMAN® BACTISEAL®82174982-17492024-11-20
10381780537021CODMAN® BACTISEAL®82175082-17502024-11-20
10381780537038CODMAN® BACTISEAL®82308782-30872024-11-20
10381780537045CODMAN® BACTISEAL®82308882-30882024-11-20
10381780537052CODMAN® BACTISEAL®NS0338NS03382024-11-20
10381780537069CODMAN® BACTISEAL®NS0339NS03392024-11-20
10381780537076CODMAN® BACTISEAL®NS0340NS03402024-11-20
10381780537083CODMAN® BACTISEAL®NS0343NS03432024-11-20
10381780537090CODMAN® HAKIM® BACTISEAL®NS5048NS50482024-11-20

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
B775635CK0PHASORPHASOR HEALTH LLCHBG2026-01-19
30381780544382Integra®INTEGRA PAIN MANAGEMENTHBG2025-08-20
30381780544399Integra®INTEGRA PAIN MANAGEMENTHBG2025-08-20
10381780537304Integra®INTEGRA PAIN MANAGEMENTHBG2024-11-19
10381780263890Integra®INTEGRA PAIN MANAGEMENTHBG2024-11-19
10381780537328Integra®INTEGRA PAIN MANAGEMENTHBG2024-11-19
10381780537335Integra®INTEGRA PAIN MANAGEMENTHBG2024-11-19
10381780537342Integra®INTEGRA PAIN MANAGEMENTHBG2024-11-19
G2843520100Drill BitNeurovention LLCHBG2024-10-17
00887482000892Symmetry Surgical®SYMMETRY SURGICAL INC.HBG2024-08-07
00842962140079HNM MEDICALHNM STAINLESS, LLC.HBG2023-04-02
00842962140086HNM MEDICALHNM STAINLESS, LLC.HBG2023-04-02
G28435201Drill BitNeurovention LLCHBG2022-06-21
00850359007959SmartTipCLEARPOINT NEURO, INC.HBG2021-04-07
10381780386964Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2021-03-02
00850359007348SmartTwistCLEARPOINT NEURO, INC.HBG2021-01-22
00850359007355SmartTipCLEARPOINT NEURO, INC.HBG2021-01-22
00850359007362SmartTipCLEARPOINT NEURO, INC.HBG2021-01-22
10381780514749CODMAN® GHAJAR GUIDEINTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2020-04-01
10381780514718CODMANINTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2020-02-28
M711LS4250Neuro & Craniofacial Fixation SystemINNO Holdings, Inc.HBG2018-08-13
M274290LBL1901Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-12-29
M274290SBL1901Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-12-29
M274RB21241Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-12-29
M274RB21251Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-12-29
M274RB21281Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-12-29
M274RB21291Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-12-29
M274RB21301Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-12-29
M274RB21311Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-12-29
M274RB21321Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-12-29