FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 00849771052890
·
Model: Cautery Tip Cleaner
·
KEY SURGICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 00849771052890
- Version / Model
- Cautery Tip Cleaner
- Catalog Number
- TC200
- Company Name
- KEY SURGICAL, INC.
- Labeler DUNS
- 604056226
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-04-24
- Public Version
- 1
- Public Version Date
- 2023-05-02
- Public Version Status
- New
- Public Device Record Key
- 77ffde52-3796-48fc-96a9-55337823fad6
Device Description
Cautery Tip Cleaner, 50mm x 50mm, sterile, pouch
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
- No
- 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 |
|---|---|---|---|---|
| GEI | Electrosurgical, cutting & coagulation & accessories | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37483 | Electrosurgical tip cleaning pad | A wad designed to be used to periodically wipe clean (i.e., remove eschar build-up) a tip (e.g., an electrode or blade) used in an electrically-mediated surgical technique for cutting, coagulating, or cauterizing tissue. The device is typically abrasive on one side to facilitate cleaning, and adhesive on the other side so that it may be conveniently affixed to an easy access object in the operative arena (e.g., surgical drape, mayo stand). It may include a radiopaque thread making it visible on x-ray. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10849771052897 | GS1 | Box | 100 | In Commercial Distribution | |
| Primary | 00849771052890 | GS1 | ||||
| Previous | 00849771030492 | GS1 |
Customer Contacts
- Phone
- +1(800)541-7995
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K151222 | 000 |