FDA UDI
In Commercial Distribution
🇺🇸 United States
Key Surgical Endoscope Brushes
DI: 00849771051794
·
Model: EB10101
·
KEY SURGICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
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Basic Information
- Brand Name
- Key Surgical Endoscope Brushes
- Primary DI
- 00849771051794
- Version / Model
- EB10101
- Catalog Number
- EB10101
- Company Name
- KEY SURGICAL, INC.
- Labeler DUNS
- 604056226
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-22
- Public Version
- 1
- Public Version Date
- 2024-04-01
- Public Version Status
- New
- Public Device Record Key
- 95b1b024-b078-4a03-a369-adac4215bbb8
Device Description
Endoscope Brush, Channel Brush, 10mm Diam, 30mm BAL, 5mm Diam, 20mm BAL
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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MNL | ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE | Gastroenterology, Urology | 876.1500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38835 | Surgical instrument/endoscope cleaning utensil, single-use | A non-absorbent, non-powered, hand-held device in the form of a brush, a wire, strip of metal, or handle intended to clean the exterior and/or interior (lumen) of a surgical instrument (e.g., bur, reamer, bone tap, suturing device, sheath/shaft, ultrasonic surgical handpiece) and/or endoscope. The bristles, fibres or spines of brushes may be mounted along a single plane or radiate out around a central shaft, and may be soft or stiff; the shaft/handle of brushes may be flexible or rigid. The device may be used to clean endoscopic or open-surgery instruments, and it may have a handle or a connector/adaptor at the proximal end. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10849771051791 | GS1 | Box | 100 | In Commercial Distribution | |
| Primary | 00849771051794 | GS1 | ||||
| Package | 20849771051798 | GS1 | Case | 5 | In Commercial Distribution | |
| Previous | 00849771040514 | GS1 |
Customer Contacts
- Phone
- +1(800)541-7995
- [email protected]