FDA UDI
In Commercial Distribution
🇺🇸 United States
RELI
DI: 10386120006106
·
Model: 16-0311
·
MYCO MEDICAL SUPPLIES INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
Basic Information
- Brand Name
- RELI
- Primary DI
- 10386120006106
- Version / Model
- 16-0311
- Catalog Number
- 16-0311
- Company Name
- MYCO MEDICAL SUPPLIES INC.
- Labeler DUNS
- 879187821
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2020-09-25
- Public Version
- 1
- Public Version Date
- 2020-10-05
- Public Version Status
- New
- Public Device Record Key
- 588cde7f-72ae-4958-9e24-36de30b92bec
Device Description
RELI® #11US Disposable Mini Scalpel SS, Bulk, Non-Sterile, 100EA/BG, 15BG/CS
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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GDX | Scalpel, One-Piece | 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 | 20386120006103 | GS1 | Case | 15 | In Commercial Distribution | |
| Primary | 10386120006106 | GS1 | ||||
| Unit of Use | 00386120006109 | GS1 |