FDA.reportPublic FDA data

CODMAN

Primary DI
10886704005117
Brand
CODMAN
Company
Cerenovus, Inc.
Model
26-1222
Catalog number
261222
Device description
CODMAN Disposable Perforator 11mm
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
10886704005117PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088670400511710886704005117

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
10886704080428ENPOWERDCB2000500DCB20005002016-09-12
10886704082293CEREBASEGS9090SDGS9090SD2020-04-13
10886704082316CEREBASEGS9080SDGS9080SD2020-04-13
10886704082323CEREBASEGS9095SDGS9095SD2020-04-13
10886704076957DELTAFILLDLF100154DLF1001542016-11-16
10886704076971DELTAFILLDLF100250DLF1002502016-11-16
10886704076988DELTAFILLDLF100258DLF1002582016-11-16
10886704077022DELTAFILLDLF100208DLF1002082016-11-16
10886704077039DELTAFILLDLF100310DLF1003102016-11-16
10886704077046DELTAFILLDLF100308DLF1003082016-11-16
10886704077053DELTAFILLDLF100410DLF1004102015-09-20
10886704077060DELTAFILLDLF100408DLF1004082015-09-20
10886704077077DELTAFILLDLF100510DLF1005102016-11-16
10886704077176DELTAFILLDLF182260DLF1822602016-11-16
10886704077183DELTAFILLDLF182460DLF1824602016-11-16
10886704077244DELTAXSFTDLX100151DLX1001512015-09-20
10886704077251DELTAXSFTDLX100152DLX1001522015-09-20
10886704077268DELTAXSFTDLX100153DLX1001532015-09-20
10886704077275DELTAXSFTDLX100254DLX1002542015-09-20
10886704077282DELTAXSFTDLX100256DLX1002562015-09-20

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05999860261056NeuroLineEMD Endoszkóp Műszer Gyártó és Kereskedelmi Korlátolt Felelősségű TársaságHBF2025-09-16
05999860261230NeuroLineEMD Endoszkóp Műszer Gyártó és Kereskedelmi Korlátolt Felelősségű TársaságHBF2025-09-16
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04054462123056Evonosevonos GmbH & Co. KGHBF2024-04-25
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