FDA UDI
In Commercial Distribution
🇺🇸 United States
EXEL SRGCL BLADE,S-S, SIZE:10
DI: 00020221295009
·
Model: 29500
·
Exel International
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- EXEL SRGCL BLADE,S-S, SIZE:10
- Primary DI
- 00020221295009
- Version / Model
- 29500
- Catalog Number
- 29500
- Company Name
- Exel International
- Labeler DUNS
- 180572216
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-17
- Public Version
- 1
- Public Version Date
- 2023-03-27
- Public Version Status
- New
- Public Device Record Key
- fe7d35ef-c3da-4288-87e2-837e4b406a26
Device Description
EXEL SRGCL BLADE,S-S, SIZE:10; 100/BX, 1000/CS, 10CS/CRTN
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 |
|---|---|---|---|---|
| GES | Blade, 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 |
|---|---|---|---|---|---|---|
| Package | 10020221295006 | GS1 | Inner box | 100 | In Commercial Distribution | |
| Primary | 00020221295009 | GS1 | ||||
| Package | 20020221295003 | GS1 | Outer box | 10 | In Commercial Distribution | |
| Package | 30020221295000 | GS1 | Shipping carton | 10 | In Commercial Distribution |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius