FDA UDI
In Commercial Distribution
🇺🇸 United States
Dakota Knife Handle
DI: M364110204FD10
·
Model: 11-0204-FD1
·
MEDICAL DESIGNS LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Dakota Knife Handle
- Primary DI
- M364110204FD10
- Version / Model
- 11-0204-FD1
- Catalog Number
- 11-0204-FD1
- Company Name
- MEDICAL DESIGNS LLC
- Labeler DUNS
- 003815548
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-27
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 7385439e-1b48-41c1-a0fe-4127131b2277
Device Description
The Dakota Knife® Handle used in conjunction with the Dakota Knife® Blade is designed for use in open, limited open, and minimally invasive carpal tunnel release surgery. The Dakota Knife® Blade is a single-use, disposable cutting instrument for transecting the transverse carpal ligament.
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 |
|---|---|---|---|---|
| FZX | Guide, Surgical, Instrument | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12235 | Scalpel handle, reusable | A device that is an interchangeable component of a scalpel and that functions as a handle designed to mount a compatible blade. This device with the blade become a single-bladed surgical instrument intended to be used by a physician for cutting or dissecting tissue. The device is typically made of metal (e.g., stainless steel or brass). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M364110204FD10 | HIBCC | ||||
| Direct Marking | M36411020410 | HIBCC |
Customer Contacts
- Phone
- 605-275-1032
- [email protected]