FDA UDI
In Commercial Distribution
🇺🇸 United States
Endo-Kerrison-Shaft
DI: 04250337117971
·
Model: EKS32303040CU
·
Joimax GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Endo-Kerrison-Shaft
- Primary DI
- 04250337117971
- Version / Model
- EKS32303040CU
- Company Name
- Joimax GmbH
- Labeler DUNS
- 344267187
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-12
- Public Version
- 1
- Public Version Date
- 2025-03-20
- Public Version Status
- New
- Public Device Record Key
- 3a30cc01-2e0d-4754-9faf-7f791d37be39
Device Description
The Endo-Kerrison punches are hand-held manual surgical instruments for use in minimally invasive spinal surgery with a cutting/punching action used to cut small cross-sectional pieces of bone or a segment of hard tissue, cartilage and ligaments from the vertebral bodies and/or associated tissues.
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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LRY | Punch, Surgical | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35732 | Rigid endoscopic biopsy forceps, reusable | A rigid, manual, non-electrosurgical instrument intended to obtain tissue specimens during endoscopic procedures (e.g., laparoscopy, thoracoscopy, spinoscopy, arthroscopy). It is typically constructed as a long instrument with one sliding and one stationary rod whose distal ends are equipped with scissors-like cups with cutting edge rims, which are operated by a control handle at the proximal end of the instrument. It is introduced into the body through an artificial orifice of the body or the working channel of the endoscope. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04250337117971 | GS1 |