FDA UDI
In Commercial Distribution
🇺🇸 United States
Remora Smoke and Fluid Evacuation System
DI: 00842071139346
·
Model: EST9000
·
APPLIED MEDICAL TECHNOLOGY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Remora Smoke and Fluid Evacuation System
- Primary DI
- 00842071139346
- Version / Model
- EST9000
- Catalog Number
- EST9000, ST9000
- Company Name
- APPLIED MEDICAL TECHNOLOGY, INC.
- Labeler DUNS
- 038101861
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-11-22
- Public Version
- 1
- Public Version Date
- 2024-12-02
- Public Version Status
- New
- Public Device Record Key
- d8232ceb-dc64-421b-8e91-81c999854a9f
Device Description
Remora Smoke and Fluid Evacuation System (Sterile, Pouched), MDR
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
- Yes
- 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 |
|---|---|---|---|---|
| 37861 | Surgical plume evacuation system | A mains electricity (AC-powered) assembly of devices intended to capture smoke generated during open surgical procedures involving tissue ablation (e.g., laser surgery, electrocautery, electrosurgical diathermy device). It captures the plume (smoke composed of carbonized cell fragments, water vapour, and hydrocarbons from vaporized tissue) near its origin before it becomes dispersed and causes surgical staff respiratory exposure. It consists of a capture tube or wand and four elements to evacuate smoke: user interface, filters, suction source, and exhaust. The system may be mobile (on wheels) and used during closed surgical procedures (e.g., endoscopy, laparoscopy) to clear the view. See also: Gas/fume evacuation system; Anaesthetic gas scavenging unit; Suction system filter, plume particulate; Orthopaedic cement fume evacuator; Surgical plume evacuation system tube | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00842071139360 | GS1 | Box (ST9000) | 10 | In Commercial Distribution | |
| Primary | 00842071139346 | GS1 |
Customer Contacts
- Phone
- (440) 717-4000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K971758 | 000 |