FDA UDI
In Commercial Distribution
🇺🇸 United States
V. Mueller
DI: 10885403035180
·
Model: CH8580
·
CAREFUSION 2200, INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- V. Mueller
- Primary DI
- 10885403035180
- Version / Model
- CH8580
- Catalog Number
- CH8580
- Company Name
- CAREFUSION 2200, INC
- Labeler DUNS
- 832696038
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-17
- Public Version
- 2
- Public Version Date
- 2024-02-02
- Public Version Status
- Update
- Public Device Record Key
- 516fda1a-6352-4bbe-b7ac-0a8e0ef71661
Device Description
V. Mueller JACOBSON ENDARTERECTOMY SPATULA, STRAIGHT SEMI-SHARP BLADE 10X1MM WIDE OVERALL LENGTH 7" (17.8CM)
Device Characteristics
- Single Use
- No
- 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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DWS | INSTRUMENTS, SURGICAL, CARDIOVASCULAR | Cardiovascular | 870.4500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38127 | Vascular spatula | A hand-held surgical instrument designed to be used within the vasculature (a blood vessel) to scrape, manipulate, and remove tissue therein. It typically made of high-grade stainless steel and consists of a flat blunt blade (no sharp edges) that is either single-ended or double-ended (a blade at either end). It is available with a variety of blade designs, e.g., curved and spoon-shaped or curved and straight. The handle can be placed proximally or be formed from its middle section and may be more prominent/serrated. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10885403035180 | GS1 |
Customer Contacts
- Phone
- +1(800)323-9088
- [email protected]