FDA UDI
In Commercial Distribution
🇺🇸 United States
BONE CHISEL 5mm CH
DI: D928105305CH0
·
Model: 10-5305CH
·
W.H. Holden, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BONE CHISEL 5mm CH
- Primary DI
- D928105305CH0
- Version / Model
- 10-5305CH
- Company Name
- W.H. Holden, Inc.
- Labeler DUNS
- 183854322
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-10
- Public Version
- 1
- Public Version Date
- 2023-10-18
- Public Version Status
- New
- Public Device Record Key
- cded6195-400c-48ab-a312-af19f4e5e2ca
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 10828 | Nasal chisel | A single-bladed, surgical instrument, bevelled on one side that is used to cut and shape the nasal bones 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. The distal end (the cutting or shaping edge) is sharp, often flat, but can be curved (concave) in design. 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 | D928105305CH0 | HIBCC |