FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Endoscopy trolley monitor arm
DI: 04056634045487
·
Model: JESTNA
·
Joimax GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Endoscopy trolley monitor arm
- Primary DI
- 04056634045487
- Version / Model
- JESTNA
- Catalog Number
- JESTNA
- Company Name
- Joimax GmbH
- Labeler DUNS
- 344267187
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-01-16
- Public Version
- 2
- Public Version Date
- 2023-06-02
- Public Version Status
- Update
- Public Device Record Key
- 0f59553f-9788-4f81-8902-76738fbf3e2b
- Distribution End Date
- 2023-05-31
Device Description
Lat. Mounting Arm for joimax® Endoscopic Trolley
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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| BZN | CART, EMERGENCY, CARDIOPULMONARY (EXCLUDING EQUIPMENT) | Anesthesiology | 868.6175 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32579 | Spinal endoscopic-access system | An assembly of devices used to gain access to the spine by dilation of the overlying tissues for the placement and support of an endoscope. It typically includes the endoscope, a light source, a fibreoptic light cable, a camera control unit, a camera, and cannulae (portals). It is used for posterior or anterior access and visualization of a surgical area of the cervical, thoracic, or lumbar spine, allowing the surgeon to perform a procedure such as, a discectomy, nucleotomy, spinal fusion, spinal decompression, foraminotomy, or insertion of spinal implants. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04056634045487 | GS1 |
Customer Contacts
- Phone
- +497212551407010
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | height adjustable with swivel arm, VESA 75/100 |