FDA UDI
In Commercial Distribution
🇺🇸 United States
RENOVATIO
DI: 20850046400142
·
Model: REN-HARP-19-60
·
Bonago Medical Solutions LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- RENOVATIO
- Primary DI
- 20850046400142
- Version / Model
- REN-HARP-19-60
- Company Name
- Bonago Medical Solutions LLC
- Labeler DUNS
- 118712410
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2022-11-15
- Public Version
- 2
- Public Version Date
- 2023-06-02
- Public Version Status
- Update
- Public Device Record Key
- 5ac8f029-0d0d-4f49-856a-9b38702a4b2f
Device Description
HARPOON PDO THREAD BIOABSORBABLE WITH NEEDLE-STERILIZED PACKAGE
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
- Yes
- 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
- 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 |
|---|---|---|---|---|
| NEW | Suture, Surgical, Absorbable, Polydioxanone | General, Plastic Surgery | 878.4840 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44829 | Composite-polymer suture | A multiple-strand (multifilament), synthetic thread made from strands of both a bioabsorbable polyester polymer (e.g., polydioxanone) and non-bioabsorbable polymer [e.g., polyethylene (PE)], intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues (includes use in orthopaedic surgeries). It is coated with a copolymer and may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. It provides temporary wound support until the wound sufficiently heals to withstand normal stress. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00850046400155 | GS1 | ||||
| Primary | 20850046400142 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K160761 | 000 |