FDA UDI
In Commercial Distribution
🇺🇸 United States
SchureMed
DI: 00810014600758
·
Model: 800-0142-EU-SKY
·
SCHUERCH CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SchureMed
- Primary DI
- 00810014600758
- Version / Model
- 800-0142-EU-SKY
- Catalog Number
- 800-0142-EU-SKY
- Company Name
- SCHUERCH CORPORATION
- Labeler DUNS
- 964322929
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-06-13
- Public Version
- 2
- Public Version Date
- 2021-09-02
- Public Version Status
- Update
- Public Device Record Key
- a398018a-4e75-4a81-8876-de653a0b5784
Device Description
E-Z Lift Beach Chair (EU) - Skytron
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FWZ | Operating Room Accessories Table Tray | General, Plastic Surgery | 878.4950 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38448 | General examination/treatment chair, manual | A manually-operated device designed to support and position the patient in a seated or reclined posture for easy access and patient comfort during a diagnostic examination, medical treatment, and/or surgical procedure across specialties. It usually has moveable components and may include special features such as a raising and lowering mechanism and removable arms. For chairs involving the use of medical systems that emit and/or detect energy (e.g., ionizing or non-ionizing radiation, ultrasound, heat, light) see the respective chair terms for those systems. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810014600758 | GS1 |
Customer Contacts
- Phone
- 781-982-7000
- [email protected]