FDA UDI
In Commercial Distribution
🇺🇸 United States
Rospital Productos Medicos
DI: 00812460028063
·
Model: SBP20
·
ATLAS MEDICAL PRODUCTS LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Rospital Productos Medicos
- Primary DI
- 00812460028063
- Version / Model
- SBP20
- Catalog Number
- SBP20
- Company Name
- ATLAS MEDICAL PRODUCTS LLC
- Labeler DUNS
- 013112308
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-13
- Public Version
- 3
- Public Version Date
- 2021-01-22
- Public Version Status
- Update
- Public Device Record Key
- 6900a97a-784f-47b1-94d2-7fd7f83eb170
Device Description
SURGICAL BLADES WITH PLASTIC HANDLE - #20 EA.
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
- Yes
- 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 | 10812460028060 | GS1 | INNER | 10 | In Commercial Distribution | |
| Primary | 00812460028063 | GS1 | ||||
| Package | 20812460028067 | GS1 | CASE | 50 | In Commercial Distribution |
Customer Contacts
- Phone
- 786-473-9436
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | SURGICAL BLADES WITH PLASTIC HANDLE - #20 EA. |