FDA UDI
In Commercial Distribution
🇺🇸 United States
MSI Precision Specialty Instruments
DI: 00194613088262
·
Model: D9042
·
Med Saver, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MSI Precision Specialty Instruments
- Primary DI
- 00194613088262
- Version / Model
- D9042
- Company Name
- Med Saver, Inc.
- Labeler DUNS
- 556623486
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-15
- Public Version
- 2
- Public Version Date
- 2025-07-30
- Public Version Status
- Update
- Public Device Record Key
- f1025e0d-b1b4-45f6-8819-4b28a7930bcc
Device Description
Alexander Mastoid Chisel, Straight, 8mm Wide Head, Overall Length 7" (180mm)
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EMM | CHISEL, OSTEOTOME, SURGICAL | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10827 | Mastoid chisel | A single-bladed, surgical instrument, bevelled on one side with a flat cutting edge that is used to cut and shape the mastoid process (the large projection of the temporal bone of the skull found immediately behind each ear) during ear/nose/throat (ENT) surgery. It is hand-held by the surgeon who will use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. It is typically a one-piece instrument made of high-grade stainless steel. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00194613088262 | GS1 |
Customer Contacts
- Phone
- +1(610)935-8181
- [email protected]