AccessGUDID - DEVICE: Hubly Auto-Stop Drill (00860007807473)

GUDID

Device Identifier (DI) Information

Brand Name: Hubly Auto-Stop Drill
Version or Model: H0271
Commercial Distribution Status: In Commercial Distribution
Catalog Number: H0271
Company Name: Hubly, Inc. DBA Hubly Surgical

Primary DI Number: 00860007807473
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 and Accessory Kit - Without Drugs - 2.7mm

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:	Yes
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: 1c159249-2e11-4e21-8cd5-dfde80b26664
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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