FDA.reportPublic FDA data

CODMAN

Primary DI
10886704005124
Brand
CODMAN
Company
Cerenovus, Inc.
Model
26-1223
Catalog number
261223
Device description
CODMAN Disposable Perforator 9mm
Published
2016-06-30
Public version status
Update
Distribution status
Not 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
HBFDRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBFDrills, Burrs, Trephines & Accessories (Compound, Powered)Neurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071931000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071931000CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223Codman & Shurtleff, Inc.2007-10-22HBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886704005124PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088670400512410886704005124

GMDN Terms#

Term, Definition table
TermDefinition
Automatic cranial perforator, single-useA sterile, metallic rotary endpiece designed to cut a circular section, or sections, of the skull vault (calvarium) to provide access to the interior for diagnostic/therapeutic purposes or for the removal of a bone flap for brain surgery. It typically consists of two coaxial drill shafts (one rotating inside the other), a drive shank that enables connection to a powered (either electrical or pneumatic) handpiece, and a built-in clutch mechanism. The inner drill shaft extends slightly beyond the outer cutter in such a way that when the inner drill shafts penetrates the inner table of the skull the clutch mechanism disengages. 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
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886704085317TRUFILL632500NA632500NA2023-10-23
10886704085324TRUFILL632400NA632400NA2023-10-23
10886704029144TRUFILL631-400631-4002014-09-20
10886704029151TRUFILL631-500631-5002014-09-20
10886704086017CEREGLIDESBC92114UGSBC92114UG2024-06-20
10886704086048CEREGLIDESBC92122UGSBC92122UG2024-06-20
10886704086079CEREGLIDESBC92130UGSBC92130UG2024-06-20
10886704086109CEREGLIDESBC92135UGSBC92135UG2024-06-20
10886704088097CEREGLIDECS71125UCS71125U2025-10-13
10886704088103CEREGLIDECS71115UCS71115U2025-10-13
10886704088110CEREGLIDECS71137UCS71137U2025-10-13
10886704088141CEREGLIDECS71132UCS71132U2025-10-13
10886704086437CEREGLIDENIC42132UNIC42132U2025-09-26
10886704086451CEREGLIDENIC42144UNIC42144U2025-09-26
10886704086475CEREGLIDENIC42160UNIC42160U2025-09-26
10886704086499CEREGLIDENIC57115UNIC57115U2025-09-26
10886704086512CEREGLIDENIC57125UNIC57125U2025-09-26
10886704086536CEREGLIDENIC57132UNIC57132U2025-09-26
10886704086550CEREGLIDENIC57137UNIC57137U2025-09-26
10886704086598CEREGLIDENIC42125U2025-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05999860261001NeuroLineEMD Endoszkóp Műszer Gyártó és Kereskedelmi Korlátolt Felelősségű TársaságHBF2025-09-16
05999860261018NeuroLineEMD Endoszkóp Műszer Gyártó és Kereskedelmi Korlátolt Felelősségű TársaságHBF2025-09-16
05999860261025NeuroLineEMD Endoszkóp Műszer Gyártó és Kereskedelmi Korlátolt Felelősségű TársaságHBF2025-09-16
05999860261032NeuroLineEMD Endoszkóp Műszer Gyártó és Kereskedelmi Korlátolt Felelősségű TársaságHBF2025-09-16
05999860261049NeuroLineEMD Endoszkóp Műszer Gyártó és Kereskedelmi Korlátolt Felelősségű TársaságHBF2025-09-16
05999860261056NeuroLineEMD Endoszkóp Műszer Gyártó és Kereskedelmi Korlátolt Felelősségű TársaságHBF2025-09-16
05999860261230NeuroLineEMD Endoszkóp Műszer Gyártó és Kereskedelmi Korlátolt Felelősségű TársaságHBF2025-09-16
05999860261247NeuroLineEMD Endoszkóp Műszer Gyártó és Kereskedelmi Korlátolt Felelősségű TársaságHBF2025-09-16
04054462020836Evonosevonos GmbH & Co. KGHBF2024-04-25
04054462020850Evonosevonos GmbH & Co. KGHBF2024-04-25
04054462020874Evonosevonos GmbH & Co. KGHBF2024-04-25
04054462020898Evonosevonos GmbH & Co. KGHBF2024-04-25
04054462020911Evonosevonos GmbH & Co. KGHBF2024-04-25
04054462020935Evonosevonos GmbH & Co. KGHBF2024-04-25
04054462020959Evonosevonos GmbH & Co. KGHBF2024-04-25
04054462020973Evonosevonos GmbH & Co. KGHBF2024-04-25
04054462122981Evonosevonos GmbH & Co. KGHBF2024-04-25
04054462122998Evonosevonos GmbH & Co. KGHBF2024-04-25
04054462123001Evonosevonos GmbH & Co. KGHBF2024-04-25
04054462123018Evonosevonos GmbH & Co. KGHBF2024-04-25
04054462123025Evonosevonos GmbH & Co. KGHBF2024-04-25
04054462123032Evonosevonos GmbH & Co. KGHBF2024-04-25
04054462123049Evonosevonos GmbH & Co. KGHBF2024-04-25
04054462123056Evonosevonos GmbH & Co. KGHBF2024-04-25
07898959543593EasyDrill Cranial Perforator Ø14 x Ø11 x 3mmMicromar Indústria e Comércio LtdaHBF2023-10-30
07898959543609EasyDrill Cranial Perforator Ø14 x Ø11 x 1,5mmMicromar Indústria e Comércio LtdaHBF2023-10-30
07898959543616EasyDrill Cranial Perforator Ø11 x Ø7 x 3mmMicromar Indústria e Comércio LtdaHBF2023-10-30
07898959543623EasyDrill Cranial Perforator Ø9 x Ø6 x 3mmMicromar Indústria e Comércio LtdaHBF2023-10-30
07898959543555EasyDrill Cranial Perforator Ø9 x Ø6 x 3mmMicromar Indústria e Comércio LtdaHBF2022-12-02
07898959543562EasyDrill Cranial Perforator Ø11 x Ø7 x 3mmMicromar Indústria e Comércio LtdaHBF2022-12-02