FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Medical Action Industries
DI: 10809160003770
·
Model: 56216
·
MEDICAL ACTION INDUSTRIES INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Medical Action Industries
- Primary DI
- 10809160003770
- Version / Model
- 56216
- Company Name
- MEDICAL ACTION INDUSTRIES INC.
- Labeler DUNS
- 092364462
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-20
- Public Version
- 4
- Public Version Date
- 2021-10-22
- Public Version Status
- Update
- Public Device Record Key
- c00e3493-145a-4a13-bda9-ed3987b8f9e8
- Distribution End Date
- 2021-10-19
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- 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 |
|---|---|---|---|---|
| KDC | INSTRUMENT, SURGICAL, DISPOSABLE | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47569 | Scalpel, single-use | A hand-held, manual surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The blade is typically made of high-grade stainless steel alloy or carbon steel and the handle is often made of plastic. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20809160003777 | GS1 | 20 | Not in Commercial Distribution | 2021-10-19 | |
| Primary | 10809160003770 | GS1 | ||||
| Package | 30809160003774 | GS1 | 20 | Not in Commercial Distribution | 2021-10-19 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Type
- Special Storage Condition, Specify
- Special Conditions
- store at room temperature