FDA UDI
In Commercial Distribution
🇺🇸 United States
Southmedic Instrument Cleaning Brushes
DI: 10620974004018
·
Model: PKM16
·
Southmedic Incorporated
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
3
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Basic Information
- Brand Name
- Southmedic Instrument Cleaning Brushes
- Primary DI
- 10620974004018
- Version / Model
- PKM16
- Catalog Number
- PKM16
- Company Name
- Southmedic Incorporated
- Labeler DUNS
- 246848147
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 3
- Record Status
- Published
- Publish Date
- 2025-01-15
- Public Version
- 1
- Public Version Date
- 2025-01-23
- Public Version Status
- New
- Public Device Record Key
- 3bdb7ce8-4e60-40be-8b24-1804b9bd8949
Device Description
Brush-Toothbrush Style, Double End, Nylon, 7"
Device Characteristics
- Single Use
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEC | BRUSH, SCRUB, OPERATING-ROOM | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34878 | Surgical instrument/endoscope cleaning utensil, reusable | 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 reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00620974004011 | GS1 | ||||
| Primary | 10620974004018 | GS1 |
Customer Contacts
- Phone
- +1(705)726-9383
- [email protected]