FDA UDI
In Commercial Distribution
🇺🇸 United States
GENESYS CROSSFT, HI-FI, LINVATEC SRS
DI: 20845854034603
·
Model: CFBC-5503N
·
Conmed Corporation
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- GENESYS CROSSFT, HI-FI, LINVATEC SRS
- Primary DI
- 20845854034603
- Version / Model
- CFBC-5503N
- Catalog Number
- CFBC-5503N
- Company Name
- Conmed Corporation
- Labeler DUNS
- 071595540
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-17
- Public Version
- 2
- Public Version Date
- 2024-08-05
- Public Version Status
- Update
- Public Device Record Key
- 297b580a-b30a-4000-b0a5-1e480196aa49
Device Description
GENESYS CrossFT 5.5 mm Suture Anchor, w/3 Hi-Fi #2 (5 metric) Sutures w/Needles
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 |
|---|---|---|---|---|---|---|
| Package | 30845854034600 | GS1 | Carton | 1 | In Commercial Distribution | |
| Primary | 20845854034603 | GS1 | ||||
| Previous | 10845854034606 | GS1 |
Customer Contacts
- Phone
- +1(866)426-6633
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K101100 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- KEEP DRY
- Type
- Storage Environment Temperature
- Temperature Range
- High: 104 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- High: 40 Degrees Celsius