FDA UDI
In Commercial Distribution
🇺🇸 United States
Tri-Gate Disposable Cannula
DI: 00818614020549
·
Model: 00-8590
·
MEDLINE INDUSTRIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Tri-Gate Disposable Cannula
- Primary DI
- 00818614020549
- Version / Model
- 00-8590
- Company Name
- MEDLINE INDUSTRIES, INC.
- Labeler DUNS
- 025460908
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-05-10
- Public Version
- 3
- Public Version Date
- 2024-09-30
- Public Version Status
- Update
- Public Device Record Key
- e802e603-d696-47ce-95c8-d8b19cfbf1e0
Device Description
8.5 ID x 90mm Tri-Gate Disposable Cannula
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
- 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
- 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 |
|---|---|---|---|---|
| GEA | Cannula, Surgical, General & Plastic Surgery | General, Plastic Surgery | 878.4800 | 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 | 10818614020546 | GS1 | Box | 6 | In Commercial Distribution | |
| Primary | 00818614020549 | GS1 |