FDA UDI
In Commercial Distribution
🇺🇸 United States
HEALIX ADVANCE
DI: 10886705023462
·
Model: 222330
·
DEPUY MITEK, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HEALIX ADVANCE
- Primary DI
- 10886705023462
- Version / Model
- 222330
- Catalog Number
- 222330
- Company Name
- DEPUY MITEK, LLC
- Labeler DUNS
- 190572854
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-01
- Public Version
- 5
- Public Version Date
- 2019-03-21
- Public Version Status
- Update
- Public Device Record Key
- 525b11ee-2b65-4413-81e0-11e989ac02e2
Device Description
HEALIX ADVANCE KNOTLESS BR ANCHOR TCP/PLGA Absorbable Anchor 4.75mm
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 | 10886705023462 | GS1 |
Customer Contacts
- Phone
- +1(800)255-2500
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K130917 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- High: 77 Degrees Fahrenheit
- Type
- Handling Environment Temperature
- Temperature Range
- High: 77 Degrees Fahrenheit
- Type
- Handling Environment Temperature
- Temperature Range
- High: 25 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- High: 25 Degrees Celsius