Identity
- Trade Name
- Bone Perforator, Pencil Tip EUDAMEDAwl FDA UDI
- Generic Name
- Bone awl, reusable FDA UDI
- Device Name
- Bone Perforator, Pencil Tip EUDAMEDFDA UDI
- Model / Reference
- JMSNB20 EUDAMEDFDA UDI
- Description
- Bone Perforator, Pencil Tip FDA UDI
Identifiers
- Catalog Number
- JMSNB20 FDA UDI
- Primary DI / UDI-DI
- 04250337110644 EUDAMEDFDA UDI
- Basic UDI-DI
- 42503371AWLPERE7 EUDAMED
- Direct Marketing DI
- 04250337110644 EUDAMED
- FDA Product Code
- HWJ FDA UDI
- EMDN Code
- L1113 NEUROSURGERY BURS AND TIPS, REUSABLE EUDAMED
- GMDN Term
- Bone awl, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Bone awl, reusable
Awl by Joimax, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Bone awl, reusable.
- Vital™ MIS Spinal Fixation System — BIOMET SPINE LLC · Class I
- Trigen — Smith & Nephew, Inc. · Class I
- Navigated Instruments — EVOLUTION SPINE, LLC · Class II
- PYRENEES Cervical Plate System — K2M, INC. · Class I
- Awl — SIGNATURE ORTHOPAEDICS PTY LTD · Class I
- CONMED — Conmed Corporation · Class I
- Sklar® — Sklar Corporation · Class I
- Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Joimax, Inc.
Sources (2)
- FDA UDI 01e184f4-d19e-4126-af68-e1b33edec5d0 36 fields · synced Jun 18, 2026
- EUDAMED 7eb0a252-55cd-49f6-bb5e-5fc21d21fe57 61 fields · synced Jun 18, 2026