FDA.reportPublic FDA data

CODMAN

Primary DI
10381780514718
Brand
CODMAN
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
80-1181
Catalog number
801181
Device description
CODMAN Subarachnoid Drill
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

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
10886704035954PreviousGS10
10381780514718PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088670403595410886704035954
1038178051471810381780514718

GMDN Terms#

Term, Definition table
TermDefinition
Fluted surgical drill bit, reusableA shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is usually inserted into a surgical power tool or a surgical hand drill/brace. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
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 DI, Brand, Model table
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 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
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