FDA UDI
In Commercial Distribution
🇺🇸 United States
Greenwald Surgical Company, Inc.
DI: 10801334005474
·
Model: 28230-01
·
GRACE MANUFACTURING, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Greenwald Surgical Company, Inc.
- Primary DI
- 10801334005474
- Version / Model
- 28230-01
- Catalog Number
- BT83A
- Company Name
- GRACE MANUFACTURING, INC.
- Labeler DUNS
- 607903382
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 9f88f2d2-119f-4c0f-b6db-82abc7dd844e
Device Description
Cervical Cyst Removal Electrode. Bi-Terminal.
Device Characteristics
- Single Use
- No
- 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
- Yes
- 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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization, Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HIN | Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) | Obstetrics/Gynecology | 884.4150 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61951 | Endoscopic electrosurgical electrode, bipolar, reprocessed | A sterile, invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a bipolar configuration (i.e., without a return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps) which may include a lumen for suction/irrigation; it does not include a handpiece/housing with any form of electrical or mechanical controls (e.g., does not include controlling ring-handles). This is a previously used single-use device that has been processed for an additional single-use patient application. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10801334005474 | GS1 |