FDA UDI
In Commercial Distribution
🇺🇸 United States
Hubly Auto-Stop Drill
DI: 00860007807466
·
Model: H0270
·
Hubly, Inc. DBA Hubly Surgical
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Hubly Auto-Stop Drill
- Primary DI
- 00860007807466
- Version / Model
- H0270
- Catalog Number
- H0270
- Company Name
- Hubly, Inc. DBA Hubly Surgical
- Labeler DUNS
- 117060126
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-17
- Public Version
- 1
- Public Version Date
- 2025-04-25
- Public Version Status
- New
- Public Device Record Key
- 0031a010-d07d-43fd-81d6-f090a2b695c2
Device Description
Hubly Auto-Stop Drill and Accessory Kit - With Drugs - 2.7mm
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | Neurology | 882.4310 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860007807466 | GS1 |
Customer Contacts
- Phone
- 1-884-482-5942
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K230619 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 2.7 | Millimeter |
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 15 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -30 – 60 Degrees Celsius