FDA UDI
In Commercial Distribution
🇺🇸 United States
CARDINAL HEALTH
DI: 10885380103407
·
Model: D2862-12A
·
Cardinal Health 200, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- CARDINAL HEALTH
- Primary DI
- 10885380103407
- Version / Model
- D2862-12A
- Catalog Number
- D2862-12A
- Company Name
- Cardinal Health 200, LLC
- Labeler DUNS
- 961027315
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-04-09
- Public Version
- 4
- Public Version Date
- 2021-01-22
- Public Version Status
- Update
- Public Device Record Key
- 7077e2c5-9daa-4776-9159-69841dec85f1
Device Description
Sterile Surgical Blade Size 12
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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 |
|---|---|---|---|---|
| EMF | KNIFE, SURGICAL | 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 | 50885380103405 | GS1 | CASE | 12 | In Commercial Distribution | |
| Package | 20885380103404 | GS1 | BOX | 12 | In Commercial Distribution | |
| Primary | 10885380103407 | GS1 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 25 – 60 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 20 – 25 Degrees Celsius