FDA.reportPublic FDA data

CODMAN

Primary DI
10886704035947
Brand
CODMAN
Company
CODMAN & SHURTLEFF, INC.
Model
80-1180
Catalog number
801180
Device description
CODMAN Subarachnoid Screw
Published
2016-06-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HBGDRILLS, BURRS, TREPHINES & ACCESSORIES (MANUAL)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBGDrills, Burrs, Trephines & Accessories (Manual)Neurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886704035947PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088670403594710886704035947

GMDN Terms#

Term, Definition table
TermDefinition
Intracerebral sensor catheterA 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 measure intracranial parameters [e.g., intracranial pressure (ICP), temperature, partial pressure of oxygen (pO2)]; it may in addition be intended for cerebrospinal fluid (CSF) drainage and/or 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 table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
607846297
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 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
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
10381780514701CODMANINTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2020-02-28
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