Identity
- Trade Name
- JUGGERKNOT FLEX DRILL BIT FDA UDI
- Generic Name
- Fluted surgical drill bit, single-use FDA UDI
- Model / Reference
- 912037 FDA UDI
Identifiers
- Catalog Number
- 912037 FDA UDI
- Primary DI / UDI-DI
- 00880304516564 FDA UDI
- FDA Product Code
- MBI FDA UDI
- GMDN Term
- Fluted surgical drill bit, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Fluted surgical drill bit, single-use
Juggerknot Flex Drill Bit by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fluted surgical drill bit, single-use.
- LEVEL ONE — KLS-Martin L.P. · Class I
- T2 ALPHA — Stryker Corp. · Class I
- Piccolo Composite Plate System — CARBOFIX ORTHOPEDICS LTD · Class II
- Nobel Biocare® — Nobel Biocare AG · Class I
- INSTRUMENT — Howmedica Osteonics Corp. · Class I
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class I
- EVOS — Smith & Nephew, Inc. · Class I
- EBA ONE — Citieffe · Class II
Cleared under the same submission
K110145 also covers:
- JUGGERKNOT — Biomet Orthopedics, Inc.
- JUGGERKNOT — Biomet Orthopedics, Inc.
- JUGGERKNOT 1.4MM SHORT — Biomet Orthopedics, Inc.
- JUGGERKNOT CURVED KIT — Biomet Orthopedics, Inc.
- JUGGERKNOT CURVED KIT — Biomet Orthopedics, Inc.
- JUGGERKNOT CURVED KIT — Biomet Orthopedics, Inc.
- JUGGERKNOT DISPOSABLE KIT — Biomet Orthopedics, Inc.
- JUGGERKNOT DISPOSABLE SET — Biomet Orthopedics, Inc.
- JUGGERKNOT DRILL — Biomet Orthopedics, Inc.
- JUGGERKNOT FLEX OBTURATOR — Biomet Orthopedics, Inc.
- JUGGERKNOT FLEX TROCAR — Biomet Orthopedics, Inc.
- JUGGERKNOT FLEXIBLE DRILL BIT — Biomet Orthopedics, Inc.
K150768 also covers:
- JUGGERKNOT — Biomet Orthopedics, Inc.
- JUGGERKNOT — Biomet Orthopedics, Inc.
- JUGGERKNOT — Biomet Orthopedics, Inc.
- JUGGERKNOT — Biomet Orthopedics, Inc.
- JUGGERKNOT — Biomet Orthopedics, Inc.
- JUGGERKNOT CURVED KIT — Biomet Orthopedics, Inc.
- JUGGERKNOT CURVED KIT — Biomet Orthopedics, Inc.
- JUGGERKNOT DISPOSABLE KIT — Biomet Orthopedics, Inc.
- JUGGERKNOT DISPOSABLE SET — Biomet Orthopedics, Inc.
- JUGGERKNOT DRILL — Biomet Orthopedics, Inc.
- JUGGERKNOT FLEX OBTURATOR — Biomet Orthopedics, Inc.
- JUGGERKNOT FLEX TROCAR — Biomet Orthopedics, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biomet Orthopedics, Inc.
Sources (1)
- FDA UDI 2224dafe-f380-4bcb-90df-20cc2c6ec793 36 fields · synced May 31, 2026