FDA UDI
In Commercial Distribution
🇺🇸 United States
SURESTITCH™ UHMWPE Suture PEEK Button Meniscus repair Implant-Right
DI: 08903837093844
·
Model: S29-1802-TQ
·
HEALTHIUM MEDTECH LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SURESTITCH™ UHMWPE Suture PEEK Button Meniscus repair Implant-Right
- Primary DI
- 08903837093844
- Version / Model
- S29-1802-TQ
- Company Name
- HEALTHIUM MEDTECH LIMITED
- Labeler DUNS
- 916326705
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-30
- Public Version
- 1
- Public Version Date
- 2024-08-07
- Public Version Status
- New
- Public Device Record Key
- 75f6eca1-3bdd-4e32-a950-f4ea8751f9e9
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
- Yes
- 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 |
|---|---|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | 888.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66530 | Meniscus suture anchor | A non-bioabsorbable, implantable device designed for suture-based meniscal tear repair and/or meniscus allograft stabilization. It is a small, bar-shaped, synthetic polymer device with holes for passing a suture, which is typically included. It is implanted using dedicated disposable arthroscopic instruments, which may be provided with the device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08903837093844 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K230891 | 000 |