FDA UDI
In Commercial Distribution
🇺🇸 United States
ZAVATION ROD CONNECTOR
DI: 00197157016586
·
Model: 880-1213-12
·
Zavation LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ZAVATION ROD CONNECTOR
- Primary DI
- 00197157016586
- Version / Model
- 880-1213-12
- Company Name
- Zavation LLC
- Labeler DUNS
- 069472800
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-04
- Public Version
- 1
- Public Version Date
- 2025-06-12
- Public Version Status
- New
- Public Device Record Key
- e0d151b9-ad68-443e-a6ba-ce177655dd50
Device Description
ROD CONNECTOR, PARALLEL SIDE LOADING/CLOSED 12mm offset,5.5/6.0mm X 3.5/4.0mm
Device Characteristics
- Single Use
- No
- 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
- Yes
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | 888.3060 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66514 | TNF-alpha IVD, kit, chemiluminescent immunoassay | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of tumour necrosis factor-alpha (TNF-alpha) in a clinical specimen, using a chemiluminescent immunoassay method. TNF-alpha is associated with autoimmune and inflammatory disorders such as Crohn's disease, ulcerative colitis and rheumatoid arthritis. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00197157016586 | GS1 |
Customer Contacts
- Phone
- 6019191119
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K222614 | 000 |