FDA UDI
In Commercial Distribution
🇺🇸 United States
Mariner Cap
DI: 10889981220945
·
Model: 569326
·
SEASPINE ORTHOPEDICS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Mariner Cap
- Primary DI
- 10889981220945
- Version / Model
- 569326
- Catalog Number
- 569326
- Company Name
- SEASPINE ORTHOPEDICS CORPORATION
- Labeler DUNS
- 079840876
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-11-24
- Public Version
- 1
- Public Version Date
- 2020-12-02
- Public Version Status
- New
- Public Device Record Key
- 8749bd15-745c-406f-a00a-31904beb3adc
Device Description
Mariner Cap SP Crimper
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
- 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 |
|---|---|---|---|---|
| OWI | Bone fixation cerclage, sublaminar | Orthopedic | 888.3010 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44801 | Internal spinal fixation system cable tensioner | A manual, hand-held surgical instrument used during orthopaedic surgery to apply an appropriate tension to a cable that is being implanted as part of a system to provide corrective surgery for the spine. The device is typically made of high-grade stainless steel, and is designed with a low intrusion profile to minimize the surgical exposure required for tightening the cables in situ. It will also be equipped with a means for accurate and reproducible tensioning of the cable(s). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10889981220945 | GS1 |
Customer Contacts
- Phone
- +1(760)727-8399
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K201240 | 000 |