FDA UDI
In Commercial Distribution
🇺🇸 United States
Steinmann pin w. double end trocarpoint 3.2mm/229mm, 6 pcs./unit
DI: EMAHKM714590
·
Model: KM71-459
·
mahe medical gmbh
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
6
Basic Information
- Brand Name
- Steinmann pin w. double end trocarpoint 3.2mm/229mm, 6 pcs./unit
- Primary DI
- EMAHKM714590
- Version / Model
- KM71-459
- Catalog Number
- KM71-459
- Company Name
- mahe medical gmbh
- Labeler DUNS
- 342243334
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2016-06-13
- Public Version
- 3
- Public Version Date
- 2023-09-18
- Public Version Status
- Update
- Public Device Record Key
- b442fd2c-2a9f-42cf-bf15-a02b643c88e2
Device Description
Steinmann pin w. double end trocarpoint 3.2mm/229mm, 6 pcs./unit
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HTY | PIN, FIXATION, SMOOTH | Orthopedic | 888.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32854 | Orthopaedic bone pin, non-bioabsorbable | A thin, implantable rod intended to be used for the stabilization of a bone fracture or bone grafts, or for an osteotomy or arthrodesis. It is typically drilled into bone and may be smooth or threaded, solid or cannulated, and/or semi-flexible. Also known as a K-Wire, it may in addition be intended to assist with the introduction of a surgical instrument and/or implant; it is not intended for implantation into the intramedullary canal (i.e., not a nail). It is made of a material that is not chemically degraded or absorbed by natural body processes (e.g., stainless steel). Some designs may have a break-off shank and/or be coated to improve long-term fixation. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | EMAHKM714591 | HIBCC | 1 | In Commercial Distribution | ||
| Primary | EMAHKM714590 | HIBCC | ||||
| Unit of Use | EMAHKM714592 | HIBCC |
Customer Contacts
- Phone
- +49(0)746592750
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 229.0 | Millimeter | |
| Outer Diameter | 3.2 | Millimeter |
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 50 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 28 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Cool, dark & dry place