FDA UDI
In Commercial Distribution
🇺🇸 United States
Olive Cutter
DI: 04250337120209
·
Model: JSBOC154536
·
Joimax GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- Olive Cutter
- Primary DI
- 04250337120209
- Version / Model
- JSBOC154536
- Catalog Number
- JSBOC154536
- Company Name
- Joimax GmbH
- Labeler DUNS
- 344267187
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2023-09-29
- Public Version
- 1
- Public Version Date
- 2023-10-09
- Public Version Status
- New
- Public Device Record Key
- 87d19663-8557-4f25-ab77-0961aa99d559
Device Description
Olive Cutter, Olive Tip, with side protection
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
- Yes
- 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 |
|---|---|---|---|---|
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | General, Plastic Surgery | 878.4820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66786 | Spinal shaver system blade | A cutting device designed for use in a powered spinal decompression shaver system handpiece (not included) for bone and soft-tissue resection during spinal surgery. It is locked into the handpiece and typically consists of a small outer tube with a hub and a rotating inner tube with a connector that performs a rotational or reciprocating (back and forth) motion. It is typically made of high-grade stainless steel. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 04250337120155 | GS1 | ||||
| Primary | 04250337120209 | GS1 |
Customer Contacts
- Phone
- +497212551407010
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | L 150 mm / OD 4.5 mm / Olive OD 3.6 mm |