FDA UDI
In Commercial Distribution
🇺🇸 United States
Z-Guide Wire
DI: 04057217004563
·
Model: B01 253 S
·
Z-Medical GmbH + Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Z-Guide Wire
- Primary DI
- 04057217004563
- Version / Model
- B01 253 S
- Company Name
- Z-Medical GmbH + Co. KG
- Labeler DUNS
- 332068761
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-06-30
- Public Version
- 4
- Public Version Date
- 2024-03-13
- Public Version Status
- Update
- Public Device Record Key
- e4ef445a-9c51-404a-a28a-b516fcc9c5d9
Device Description
Z-Guide Wire Ø3,2 x 100
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| HTY | Pin, Fixation, Smooth | Orthopedic | 888.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65867 | Orthopaedic bone staple drill bit | A thin shaft of metal with a sharp distal end intended to drill a small diameter hole into a small bone for insertion of an orthopaedic bone staple, typically for fixation following osteotomy. It may include markings to help gauge the size of the staple to be used and is mounted into a surgical power tool or a surgical hand drill/brace. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04057217004563 | GS1 |
Customer Contacts
- Phone
- +497462945540
- [email protected]