Hummingbird®

Primary DI
00851680007199
Brand
Hummingbird®
Company
INNERSPACE NEURO SOLUTIONS, INC.
Model
STC
Catalog number
STC
Device description
STC - Skull Thickness Caliper
Published
2017-07-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWMDevice, Monitoring, Intracranial Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWMDevice, Monitoring, Intracranial PressureNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K083378000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083378000SYNERGYInnerspace, Inc.2009-09-29GWM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851680007199PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851680007199008516800071998516800071990851680007199

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose calliper, plasticA non-sterile, manually-operated, lubricant free, plastic device with an analogue Vernier scale designed to make accurate measurements of a patient's anatomy, or of other objects, during surgery, autopsy, or in other clinical settings. It is intended to make external measurements (e.g., external diameter, thickness), internal measurements (e.g., internal diameter, depth), measure length, or make step measurements (i.e., from a larger edge to a lesser edge on an object). It is typically made of reinforced plastic that cannot be steam sterilized. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1.877.486.2473customerservice@hummingbirdneuro.com

Regulatory Flags#

DUNS number
080333634
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851680007151Hummingbird®HICP200HICP2002016-11-28
00851680007168Hummingbird®H310H3102016-11-28
00851680007175Hummingbird®H110MRH110MR2016-11-28
00851680007182Hummingbird®H610MRH610MR2016-11-28
00851680007205Hummingbird®H610H6102017-07-17

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00763000428754Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-03-07
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00763000431273Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-02-13
20763000431307N/AMEDTRONIC PS MEDICAL, INC.GWM2021-02-07
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