FDA UDI
In Commercial Distribution
🇺🇸 United States
V. Mueller
DI: 10885403105203
·
Model: OS5000-007
·
STERIS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- V. Mueller
- Primary DI
- 10885403105203
- Version / Model
- OS5000-007
- Catalog Number
- OS5000007
- Company Name
- STERIS CORPORATION
- Labeler DUNS
- 021599373
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 6
- Public Version Date
- 2024-08-28
- Public Version Status
- Update
- Public Device Record Key
- 63bf713f-73fd-4484-9ebf-2107601bdb2c
Device Description
V. Mueller CRAIG NEEDLE AND GUARD 22GA ONLY FOR CRAIG BIOPSY SET
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
- No
- 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 |
|---|---|---|---|---|
| FMI | Needle, hypodermic, single lumen | General Hospital | 880.5570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60378 | Percutaneous biliary biopsy procedure kit | A collection of sterile devices intended to be used to obtain a tissue specimen from within the biliary duct system for histological analysis by a percutaneous approach, typically under fluoroscopic visualization. It typically includes flexible biopsy forceps consisting of a handle, shaft, and a standard cup for tissue sampling, and various devices required for access [e.g., needle(s), introducer(s), guidewire(s) and catheter(s)]. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10885403105203 | GS1 |
Customer Contacts
- Phone
- +1(800)548-4873
- [email protected]