FDA UDI
In Commercial Distribution
🇺🇸 United States
Coblation
DI: 20817470008993
·
Model: E3030-01
·
Smith & Nephew, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- Coblation
- Primary DI
- 20817470008993
- Version / Model
- E3030-01
- Catalog Number
- E3030-01
- Company Name
- Smith & Nephew, Inc.
- Labeler DUNS
- 045483575
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2015-08-29
- Public Version
- 7
- Public Version Date
- 2023-09-07
- Public Version Status
- Update
- Public Device Record Key
- 21449343-ed11-4d11-b681-b348f6f4be92
Device Description
SAP TUBE CLIP
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| GEI | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36003 | Arthroscopic irrigation/insufflation system | A mains electricity (AC-powered) device assembly designed to provide controlled distention and irrigation (expansion by pressure and continual flushing) of the tissue and space around a joint where arthroscopy is being performed (e.g., the knee or shoulder joint). This is achieved by filling the cavity with a sterile fluid that is pumped into the wound by the system's pump(s) and distends the tissue around the site to improve visualization and enlarge the surgical field. Suction may also be applied by the system to assist in the removal of the surgically-resected bone, cartilage, and other tissue/debris from the site. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 20817470008993 | GS1 | ||||
| Unit of Use | 00817470008999 | GS1 |
Customer Contacts
- Phone
- +1(800)238-7538
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K122652 | 000 |