FDA UDI
Not in Commercial Distribution
🇺🇸 United States
PARADIGM EZ SWITCH
DI: 20845854902414
·
Model: PEZS02
·
Conmed Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PARADIGM EZ SWITCH
- Primary DI
- 20845854902414
- Version / Model
- PEZS02
- Catalog Number
- PEZS02
- Company Name
- Conmed Corporation
- Labeler DUNS
- 071595540
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-09-13
- Public Version
- 2
- Public Version Date
- 2021-08-23
- Public Version Status
- Update
- Public Device Record Key
- ec986450-8a2b-493a-94df-f6dd0873cda4
- Distribution End Date
- 2021-08-22
Device Description
CONMED Paradigm Access Kit and EZ Switch Portal Saver System
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| KDD | Kit, surgical instrument, disposable | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44093 | Arthroscopic surgical procedure kit, non-medicated, single-use | A collection of various sterile surgical and endoscopic instruments, dressings, and additional materials intended to be used specifically to perform an arthroscopic surgical procedure. It does not contain any pharmaceuticals. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 20845854902414 | GS1 |
Customer Contacts
- Phone
- +1(800)237-0169
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- KEEP DRY