FDA UDI
In Commercial Distribution
🇺🇸 United States
Not Applicable
DI: 18904233122968
·
Model: #10
·
NIRAJ INDUSTRIES PRIVATE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
25
Basic Information
- Brand Name
- Not Applicable
- Primary DI
- 18904233122968
- Version / Model
- #10
- Catalog Number
- 02296
- Company Name
- NIRAJ INDUSTRIES PRIVATE LIMITED
- Labeler DUNS
- 650191174
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2020-07-01
- Public Version
- 1
- Public Version Date
- 2020-07-09
- Public Version Status
- New
- Public Device Record Key
- c9e3f6b5-6258-4401-9cad-93de5e316a13
Device Description
STAINLESS STEEL NON STERILE SCALPEL (SURGICAL BLADE WITH PLASTIC HANDLE & COVER) #10 BULK PACKED MYCO REORDER # 6000CST-10
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| GES | Blade, Scalpel | 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 | 28904233122965 | GS1 | Case | 250 | In Commercial Distribution | |
| Primary | 18904233122968 | GS1 | ||||
| Package | 58904233122966 | GS1 | Carton | 1000 | In Commercial Distribution | |
| Unit of Use | 08904233122961 | GS1 |