AccessGUDID - DEVICE: Hubly Auto-Stop Drill (00860007807459)

GUDID

Device Identifier (DI) Information

Brand Name: Hubly Auto-Stop Drill
Version or Model: H0272
Commercial Distribution Status: In Commercial Distribution
Catalog Number: H0272
Company Name: Hubly, Inc. DBA Hubly Surgical

Primary DI Number: 00860007807459
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117060126 *Terms of Use

Device Description: Hubly Auto-Stop Drill - 2.7mm - Drill only

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
67019	Disposable one-piece cranial drill	An 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K230619	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Humidity: between 15 and 90 Percent (%) Relative Humidity
Storage Environment Humidity: between 15 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between -20 and 60 Degrees Celsius
Storage Environment Temperature: between -30 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 2.7 Millimeter

Device Record Status

Public Device Record Key: f9941dda-8ba4-46ec-82ae-cb4525bae880
Public Version Date: April 25, 2025
Public Version Number: 1
DI Record Publish Date: April 17, 2025

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 1-844-482-5942
Email: info@hublysurgical.com

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