FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 00889024022331
·
Model: 262-08-04
·
Zimmer, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
6
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Basic Information
- Brand Name
- NA
- Primary DI
- 00889024022331
- Version / Model
- 262-08-04
- Catalog Number
- 00-0262-008-04
- Company Name
- Zimmer, Inc.
- Labeler DUNS
- 056038268
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2015-09-24
- Public Version
- 6
- Public Version Date
- 2024-07-19
- Public Version Status
- Update
- Public Device Record Key
- c805fdbb-4215-4672-a48f-4d5366cf681f
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
- 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 |
|---|---|---|---|---|
| JDW | PIN, FIXATION, THREADED | Orthopedic | 888.3040 | 2 |
| HTY | PIN, FIXATION, SMOOTH | Orthopedic | 888.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66933 | Orthopaedic bone cerclage wire | An implantable thin metallic cord intended to be tightened with a knot to form a loop or ring around a fractured orthopaedic bone and/or stabilize an implant (typically a fixation plate) for treatment. It is not rigid (i.e., not a pin/K-wire) and not intended to be used in spinal bones. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00889024022331 | GS1 | ||||
| Unit of Use | 70889024022330 | GS1 |
Customer Contacts
- Phone
- +1(800)348-2759
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K143618 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 9 | Inch | |
| Device Size Text, specify | .062 Inch, Diameter |