FDA UDI
In Commercial Distribution
🇺🇸 United States
Dakota Knife Blade®
DI: M364110204FD20
·
Model: 11-0204-FD2
·
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 Blade®
- Primary DI
- M364110204FD20
- Version / Model
- 11-0204-FD2
- Catalog Number
- 11-0204-FD2
- 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
- 4
- Public Version Date
- 2021-01-22
- Public Version Status
- Update
- Public Device Record Key
- 2137e366-aaab-45bc-944b-81b731c6139c
Device Description
The Dakota Knife® Blade is a stainless steel surgical instrument 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
- Yes
- 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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GDZ | Handle, Scalpel | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37445 | Manual scalpel blade, single-use | An interchangeable device designed to mount a compatible handle and function as the cutting edge of a scalpel. It is made of high-grade stainless steel alloy and is used as a surgical instrument to cut and dissect tissues. Safety mechanisms (e.g., a retractable protective guard made of plastic) may be included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M364110204FD20 | HIBCC | ||||
| Direct Marking | 1102042 | HIBCC |
Customer Contacts
- Phone
- 605-275-1032
- [email protected]