FDA UDI
In Commercial Distribution
🇺🇸 United States
SuperDART® ONE PASS™ Validated Channel Cleaning Device
DI: 00666416121144
·
Model: 9253
·
Primed Instruments Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
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Basic Information
- Brand Name
- SuperDART® ONE PASS™ Validated Channel Cleaning Device
- Primary DI
- 00666416121144
- Version / Model
- 9253
- Catalog Number
- 9253-25
- Company Name
- Primed Instruments Inc
- Labeler DUNS
- 254491293
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2025-06-13
- Public Version
- 1
- Public Version Date
- 2025-06-23
- Public Version Status
- New
- Public Device Record Key
- 0bbfd4f4-4ac4-47d0-8b34-b8f76d0ad08b
Device Description
BRUSH CLEANING 3 TO 4.5MM X 122CM MULTI ACTION PULL THROUGH SQUEEGEE. HIBC/UPN: M45392532
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
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 00666416121137 | GS1 | ||||
| Primary | 00666416121144 | GS1 |
Customer Contacts
- Phone
- 1-877-565-0565
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Range of Channel Size: 2.0-2.8mm | ||
| Device Size Text, specify | Brush Diameter: 3-4.5mm | ||
| Device Size Text, specify | Overall Length: 122cm |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store cleaning device in original packaging at room temperature in a dry clean location away from direct sunlight.