FDA UDI
In Commercial Distribution
🇺🇸 United States
ARGO KNOTLESS GENESYS, HI-FI
DI: 20653405988684
·
Model: KBC475TB
·
Conmed Corporation
Product Codes
2
GMDN Terms
2
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- ARGO KNOTLESS GENESYS, HI-FI
- Primary DI
- 20653405988684
- Version / Model
- KBC475TB
- Catalog Number
- KBC475TB
- Company Name
- Conmed Corporation
- Labeler DUNS
- 071595540
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-12
- Public Version
- 2
- Public Version Date
- 2024-08-14
- Public Version Status
- Update
- Public Device Record Key
- ccc13909-eb93-431a-a7dd-26cce4676f26
Device Description
4.75 mm Argo Knotless GENESYS Anchor, Hi-Fi Tape Blue/Blue
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 |
|---|---|---|---|---|
| MBI | Fastener, fixation, nondegradable, soft tissue | Orthopedic | 888.3040 | 2 |
| 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 |
| 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 |
|---|---|---|---|---|---|---|
| Package | 30653405988681 | GS1 | CARTON | 1 | In Commercial Distribution | |
| Primary | 20653405988684 | GS1 |
Customer Contacts
- Phone
- +1(866)426-6633
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K240090 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 104 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 40 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- KEEP DRY;DO NOT CRUSH;DO NOT REUSE;DO NOT RESTERILIZE