FDA UDI
In Commercial Distribution
🇺🇸 United States
Reprocessed 4mm EndoScrub Sheath, 70 deg
DI: B39019120201
·
Model: 19-12020
·
SURETEK MEDICAL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Reprocessed 4mm EndoScrub Sheath, 70 deg
- Primary DI
- B39019120201
- Version / Model
- 19-12020
- Company Name
- SURETEK MEDICAL
- Labeler DUNS
- 785616934
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-06-15
- Public Version
- 2
- Public Version Date
- 2026-01-12
- Public Version Status
- Update
- Public Device Record Key
- 8b245bb0-a29a-40f8-9ebf-d15c8853544c
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
- 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 |
|---|---|---|---|---|
| KAM | Cannula, Sinus | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48141 | Paranasal sinus irrigation catheter | A flexible tube designed to introduce fluid (e.g., saline solution) into the sinus cavities to provide irrigation for the flushing and removal of mucus, pus, and blood from the site of intervention. It typically consists of a single-lumen tube with end and/or side holes at the distal end; the proximal end is typically connected to a syringe or irrigation fluid pumping system via a Luer-lock. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B39019120201 | HIBCC |