FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Argyle
DI: 10884521029293
·
Model: 8888561050
·
Cardinal Health, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Argyle
- Primary DI
- 10884521029293
- Version / Model
- 8888561050
- Catalog Number
- 8888561050
- Company Name
- Cardinal Health, Inc.
- Labeler DUNS
- 080935429
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-06
- Public Version
- 11
- Public Version Date
- 2025-12-31
- Public Version Status
- Update
- Public Device Record Key
- 4ce985a0-9b12-4ec5-9ffb-f6cd44d5ee8d
- Distribution End Date
- 2025-12-31
Device Description
Trocar Catheter,Sharp Tip
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- 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
- 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 |
|---|---|---|---|---|
| DRC | Trocar | Cardiovascular | 870.1390 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62858 | Pleuroscopic/mediastinoscopic trocar blade | A rigid surgical instrument with a sharp or blunt tip intended to be used in conjunction with a thoracic access cannula (not included) to puncture the thoracic wall (between adjacent ribs) to facilitate placement of the cannula in the pleural and/or mediastinal cavity during a minimally-invasive procedure; it is not intended for pericardial access. It is intended to fill the lumen of a thoracic cannula and is removed once the cannula is in place. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00884521029296 | GS1 | CASE | 10 | Not in Commercial Distribution | 2016-10-07 |
| Primary | 10884521029293 | GS1 | ||||
| Package | 10884521214378 | GS1 | CASE | 10 | Not in Commercial Distribution | 2025-12-31 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 24 | French | |
| Length | 15.75 | Inch |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry;AVOID DIRECT SUNLIGHT