FDA UDI
In Commercial Distribution
🇺🇸 United States
HEX FLEX
DI: 10845854020111
·
Model: C7455
·
Conmed Corporation
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
6
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Basic Information
- Brand Name
- HEX FLEX
- Primary DI
- 10845854020111
- Version / Model
- C7455
- Catalog Number
- C7455
- Company Name
- Conmed Corporation
- Labeler DUNS
- 071595540
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2021-10-12
- Public Version
- 3
- Public Version Date
- 2024-08-14
- Public Version Status
- Update
- Public Device Record Key
- 81591074-c22f-4348-b8f4-aebec7a4f878
Device Description
HEX-FLEX CANNULA WITH DISPOSABLE OBTURATOR, 6.0 X 85 MM
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
- Yes
- 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 |
|---|---|---|---|---|
| NBH | Accessories, arthroscopic | Orthopedic | 888.1100 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58752 | Arthroscopic access cannula, single-use | A single-lumen surgical device intended to be percutaneously inserted into a joint to create an access port for an arthroscope/arthroscopic instrument during arthroscopy. The cannula is designed to facilitate the passage of surgical instruments while preventing the escape of irrigation fluid and typically includes an internal watertight seal, and a port for drainage of fluid. It is available in a variety of dimensions and/or designs and may include one or more obturator(s) to facilitate insertion. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20845854020118 | GS1 | BOX | 1 | In Commercial Distribution | |
| Primary | 10845854020111 | GS1 | ||||
| Unit of Use | 00845854020114 | GS1 |
Customer Contacts
- Phone
- +1(866)426-6633
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- KEEP DRY