FDA UDI
In Commercial Distribution
🇺🇸 United States
Steinmann pin 3 Shank End, Diamond Point 2.0mm/229mm, Sutur Passer
DI: EMAHKM718800
·
Model: KM71-880
·
mahe medical gmbh
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
6
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Steinmann pin 3 Shank End, Diamond Point 2.0mm/229mm, Sutur Passer
- Primary DI
- EMAHKM718800
- Version / Model
- KM71-880
- Catalog Number
- KM71-880
- Company Name
- mahe medical gmbh
- Labeler DUNS
- 342243334
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2016-06-10
- Public Version
- 4
- Public Version Date
- 2025-07-14
- Public Version Status
- Update
- Public Device Record Key
- 7b1da25c-bec8-4069-9530-6974e944d2f5
Device Description
Steinmann pin 3 Shank End, Diamond Point 2.0mm/229mm, Sutur Passer 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 (internal and/or external fixation). It is typically drilled into bone and may be smooth or threaded, solid or cannulated, and/or semi-flexible. Also known as a Kirschner-wire (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 non-bioabsorbable material (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 | EMAHKM718801 | HIBCC | 1 | In Commercial Distribution | ||
| Primary | EMAHKM718800 | HIBCC | ||||
| Unit of Use | EMAHKM718802 | HIBCC |
Customer Contacts
- Phone
- +49(0)746592750
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 2.0 | Millimeter | |
| Length | 229.0 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 28 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 50 Percent (%) Relative Humidity