FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Paradigm EZ Switch
DI: 20845854902339
·
Model: PEZS01
·
Conmed Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Paradigm EZ Switch
- Primary DI
- 20845854902339
- Version / Model
- PEZS01
- Catalog Number
- PEZS01
- Company Name
- Conmed Corporation
- Labeler DUNS
- 071595540
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-08-16
- Public Version
- 4
- Public Version Date
- 2022-06-17
- Public Version Status
- Update
- Public Device Record Key
- 8b33c14f-13ec-492b-8f99-8bb4a3fbf7bd
- Distribution End Date
- 2021-08-22
Device Description
Paradigm™ EZ Switch™Portal Saver System
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
- 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 |
|---|---|---|---|---|
| NBH | Accessories, arthroscopic | Orthopedic | 888.1100 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33961 | General surgical procedure kit, non-medicated, single-use | A typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 20845854902339 | GS1 |
Customer Contacts
- Phone
- +1(800)237-0169
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 8.5 mm x 150 mm |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- KEEP DRY