FDA UDI
In Commercial Distribution
🇺🇸 United States
MiniMedicut™
DI: 00634782020811
·
Model: 321BKQ
·
AMERICAN DIAGNOSTIC CORP
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- MiniMedicut™
- Primary DI
- 00634782020811
- Version / Model
- 321BKQ
- Catalog Number
- 321BKQ
- Company Name
- AMERICAN DIAGNOSTIC CORP
- Labeler DUNS
- 108999095
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- ea89ee9d-b3b8-457a-abab-742e2d481228
Device Description
MiniMedicut Shears,5-1/2", Black, Disp pkg
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LRW | Scissors, General, Surgical | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13481 | Bandage scissors, reusable | A hand-held manual instrument intended to be used to cut bandages and cloth. Typically a robust instrument, it comprises two pivoted blades provided with finger and thumb holes in the handles. The distal end of the blades may be different shapes and are usually rounded for safety; one blade may extend in front of the other and have an olive tip that is placed under the bandage. It is typically made of high-grade stainless steel and some may use carbide inserts for the cutting edge. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00634782520762 | GS1 | Master Case | 6 | In Commercial Distribution | |
| Package | 00634782820763 | GS1 | Inner pack | 12 | In Commercial Distribution | |
| Primary | 00634782020811 | GS1 |
Customer Contacts
- Phone
- 1-800-232-2670
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 5.5 | Inch |