FDA UDI
In Commercial Distribution
🇺🇸 United States
90111 Safety Cartridge #11 Carbon Steel Blade Orange Cartridge
DI: 00787551012248
·
Model: 90111
·
XODUS MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- 90111 Safety Cartridge #11 Carbon Steel Blade Orange Cartridge
- Primary DI
- 00787551012248
- Version / Model
- 90111
- Catalog Number
- 90111
- Company Name
- XODUS MEDICAL, INC.
- Labeler DUNS
- 868042664
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-08
- Public Version
- 1
- Public Version Date
- 2022-12-16
- Public Version Status
- New
- Public Device Record Key
- 5be179a2-b724-40ce-b73a-2b19085db227
Device Description
90111 Safety Cartridge #11 Carbon Steel Blade Orange Cartridge
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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Radiation Sterilization
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 | 10787551012245 | GS1 | BOX | 25 | In Commercial Distribution | |
| Primary | 00787551012248 | GS1 | ||||
| Package | 20787551012242 | GS1 | CASE | 50 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(724)337-5500
- [email protected]