FDA UDI
In Commercial Distribution
🇺🇸 United States
HEALIX ADVANCE DYNATAPE DYNACORD
DI: 10886705031115
·
Model: 280719
·
Medos International Sàrl
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HEALIX ADVANCE DYNATAPE DYNACORD
- Primary DI
- 10886705031115
- Version / Model
- 280719
- Catalog Number
- 280719
- Company Name
- Medos International Sàrl
- Labeler DUNS
- 482661753
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-10-14
- Public Version
- 2
- Public Version Date
- 2021-02-23
- Public Version Status
- Update
- Public Device Record Key
- 0357f356-98b4-4ae2-a922-37912b6eb784
Device Description
HEALIX ADVANCE PEEK Anchor w/ DYNATAPE Suture PEEK Anchor with (1) 2.5mm White/Black DYNATAPE Braided Flat Suture, 36inch (91 cm) and (1) Blue, Size 2 (5 metric) DYNACORD Braided Suture, 36inch (91cm), (1) Utility Shuttle Suture WHITE 6.5mm
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
- MR Safe
- 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 |
|---|---|---|---|---|
| HWC | Screw, fixation, bone | Orthopedic | 888.3040 | 2 |
| MBI | Fastener, fixation, nondegradable, soft tissue | Orthopedic | 888.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45062 | Tendon/ligament bone anchor, non-bioabsorbable | A non-bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that cannot be chemically degraded or absorbed via natural body processes [e.g., titanium (Ti)]. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10886705031115 | GS1 |
Customer Contacts
- Phone
- +1(800)255-2500
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K200949 | 000 |