FDA UDI
In Commercial Distribution
🇺🇸 United States
Portal Entry Kit with FlowPort® Touch, Stryker 165 mm
DI: 10810128460832
·
Model: CAT00243
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T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Portal Entry Kit with FlowPort® Touch, Stryker 165 mm
- Primary DI
- 10810128460832
- Version / Model
- CAT00243
- Catalog Number
- 625100st
- Company Name
- T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
- Labeler DUNS
- 534123013
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-18
- Public Version
- 1
- Public Version Date
- 2025-06-26
- Public Version Status
- New
- Public Device Record Key
- 9b4fd234-53e3-4b96-a202-3d086f85a32c
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | 888.4540 | 1 |
| KDD | Kit, Surgical Instrument, Disposable | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44093 | Arthroscopic surgical procedure kit, non-medicated, single-use | A collection of various sterile surgical and endoscopic instruments, dressings, and additional materials intended to be used specifically to perform an arthroscopic surgical procedure. It does not contain any pharmaceuticals. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10810128460832 | GS1 |