FDA.reportPublic FDA data

Hubly Auto-Stop Drill

Primary DI
00860007807466
Brand
Hubly Auto-Stop Drill
Company
Hubly, Inc. DBA Hubly Surgical
Model
H0270
Catalog number
H0270
Device description
Hubly Auto-Stop Drill and Accessory Kit - With Drugs - 2.7mm
Published
2025-04-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
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
00860007807466PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860007807466008600078074668600078074660860007807466

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 Diameter2.7Millimeter

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
Kit
true
Combination product
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
00860007807459Hubly Auto-Stop DrillH0272H02722025-04-17
00860007807473Hubly Auto-Stop DrillH0271H02712025-04-17
00860007807411Hubly Electric DrillH200H2002023-12-18
00860007807428Hubly Electric DrillH201H2012023-12-18
00860007807404Hubly Electric DrillH100H1002023-12-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00816589021622Brasseler Twist DrillbitMONTERIS MEDICAL INCHBE2026-07-03
04589551366217P300-2A100NAKANISHI INC.HBE2026-06-26
04589551366262P300-2A120NAKANISHI INC.HBE2026-06-26
04589551366316P300-2S100NAKANISHI INC.HBE2026-06-26
04589551366361P300-2S120NAKANISHI INC.HBE2026-06-26
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07630055505842RAPIDO MicromotorBien-Air Surgery SAHBE2023-02-10
07630055505675PM2-A70Bien-Air Surgery SAHBE2023-02-09
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07630055505729NANO MicromotorBien-Air Surgery SAHBE2023-02-09
07630055505750PM2-A70HDBien-Air Surgery SAHBE2023-02-09
07630055505767PM2-S70HDBien-Air Surgery SAHBE2023-02-09
07630055505774PM PERFOBien-Air Surgery SAHBE2023-02-09
07630055505798NANO CableBien-Air Surgery SAHBE2023-02-09
07613327504019NASTRYKER CORPORATIONHBE2021-07-08
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