FDA UDI
In Commercial Distribution
🇺🇸 United States
HEALIX ADVANCE BR 3 SUTURE ANCHOR w/DYNACORD
DI: 10886705029396
·
Model: 222002
·
Medos International Sàrl
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HEALIX ADVANCE BR 3 SUTURE ANCHOR w/DYNACORD
- Primary DI
- 10886705029396
- Version / Model
- 222002
- Catalog Number
- 222002
- Company Name
- Medos International Sàrl
- Labeler DUNS
- 482661753
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-04-16
- Public Version
- 4
- Public Version Date
- 2019-03-21
- Public Version Status
- Update
- Public Device Record Key
- c39e7dea-d135-48e7-92f5-432352fdbf3c
Device Description
HEALIX ADVANCE BR 3 SUTURE ANCHOR w/DYNACORD TCP/PLGA Absorbable Anchor (1) Blue (1) White/Blue/Green Striped (1) White/Black Striped, Size 2 (5 Metric) DYNACORD Suture, 36" (91cm) 4.5mm
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 |
|---|---|---|---|---|
| MAI | Fastener, fixation, biodegradable, soft tissue | Orthopedic | 888.3030 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45061 | Tendon/ligament bone anchor, bioabsorbable | A 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 can be chemically degraded and typically absorbed via natural body processes (e.g., a copolymer, metal alloy). | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10886705029396 | GS1 |
Customer Contacts
- Phone
- +1(800)255-2500
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K173859 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- High: 25 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- High: 77 Degrees Fahrenheit
- Type
- Handling Environment Temperature
- Temperature Range
- High: 77 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- High: 25 Degrees Celsius