FDA.reportPublic FDA data

Hubly Electric Drill

Primary DI
00860007807411
Brand
Hubly Electric Drill
Company
Hubly, Inc. DBA Hubly Surgical
Model
H200
Catalog number
H200
Device description
Hubly Electric Drill and Accessory Kit - With Drugs
Published
2023-12-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)Neurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230619000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230619000Hubly Electric Drill (H100)Hubly, Inc.2023-05-04HBE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860007807411PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860007807411008600078074118600078074110860007807411

GMDN Terms#

Term, Definition table
TermDefinition
Disposable one-piece cranial drillAn electrically-powered rotary cutting device in the form of a motorized handpiece with a permanently fixed drill bit intended to create a hole of the same diameter as the drill bit in the skull vault (calvarium). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter5Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-20 Degrees Celsius60 Degrees Celsius
Storage Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-30 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-884-482-5942info@hublysurgical.com

Regulatory Flags#

DUNS number
117060126
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860007807459Hubly Auto-Stop DrillH0272H02722025-04-17
00860007807466Hubly Auto-Stop DrillH0270H02702025-04-17
00860007807473Hubly Auto-Stop DrillH0271H02712025-04-17
00860007807428Hubly Electric DrillH201H2012023-12-18
00860007807404Hubly Electric DrillH100H1002023-12-13

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Primary DI, Brand, Company table
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