FDA.reportPublic FDA data

Hummingbird Cranial Access Kit

Primary DI
00850013266005
Brand
Hummingbird Cranial Access Kit
Company
Clearpoint Neuro, Inc.
Model
IC40
Catalog number
IC40
Published
2023-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850013266002PackageGS16In Commercial Distribution
00850013266005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085001326600210850013266002
00850013266005008500132660058500132660050850013266005

GMDN Terms#

Term, Definition table
TermDefinition
Intracerebral catheter cranial-fixation kitA collection of sterile devices intended to be used to affix an intracerebral sensor/infusion/drainage catheter on the skull of a patient. It includes cranial screws and screwing tools; it does not include the intracerebral catheter, and does not include devices intended for long-term implantation (> 30 days). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119078557
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850013266012Hummingbird® Patient MonitorHICP200HICP2002019-10-14
00850013266029Hummingbird® SynergyDuoH610H6102019-10-10
00850013266036Hummingbird® Parenchymal CatheterH110H1102019-10-10
00850013266180Hummingbird® Cranial Access Kit IC42-DIC42-D2020-01-29
00850013266197Hummingbird® Cranial Access KitIC42IC422020-01-29
00850013266203IRRAflow Tube SetICDS 030ICDS 0302023-11-02
00850013266234HummingbirdCK 402023-10-13
00850013266241HummingbirdCK 422023-10-13
00850013266272IRRAflow Cranial Access BoltICB 0102025-07-24
00868643000401IRRAflow®ICCU 020ICCU 0202019-01-22
00868643000463IRRAflow Laser Leveler PackageICLS 010ICLS 0102024-06-10
00868643000470IRRAflow Drainage Collection SystemDCS 010DCS 0102019-09-30
00868643000487Hummingbird® Cranial Access KitIC40DIC40-D2019-10-10
00868643000494Hummingbird® Cranial Access KitIC40IC402019-10-10
00850013266258IRRAflow Catheter 2.0+ICAT 0302025-05-07
00850013266227Hummingbird Cranial Access KitIC422023-12-08
00850013266104Hummingbird® HICP200 Monitor Interconnect Cable - Spacelabs 6 Pin Monitor700033270003322020-05-28
00868643000418IRRAflow® Cassette and Tube SetICDS 020ICDS 0202019-01-22
00868643000425IRRAflow® 1.5 CatheterICGS 010ICGS 0102019-01-22
00868643000432IRRAflow® 2.0 CatheterICGS 020ICGS 0202019-01-22