FDA UDI
Not in Commercial Distribution
🇺🇸 United States
SPACEBANDER
DI: 10653405005469
·
Model: HB1020
·
Conmed Corporation
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
20
Basic Information
- Brand Name
- SPACEBANDER
- Primary DI
- 10653405005469
- Version / Model
- HB1020
- Catalog Number
- HB1020
- Company Name
- Conmed Corporation
- Labeler DUNS
- 071595540
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2018-04-10
- Public Version
- 2
- Public Version Date
- 2022-06-09
- Public Version Status
- Update
- Public Device Record Key
- e4ff08f3-a7e8-4518-a9cb-6064015136fe
- Distribution End Date
- 2022-06-08
Device Description
SPACEBANDER DISPOSABLE HEMORRHOID LIGATOR
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FHN | Ligator, hemorrhoidal | Gastroenterology, Urology | 876.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35157 | Haemorrhoid ligator | A hand-held manual surgical instrument designed to deploy a ligature (e.g., a latex rubber band) to internal haemorrhoids for their removal through blood flow occlusion. It is typically made of high-grade stainless steel, and has a long shaft with a profiled clamp or grip at the distal end for holding multiple ligatures. The surgeon mechanically operates the distal clamp or grip with a handle(s) to release and deploy the ligatures as needed. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20653405005466 | GS1 | BOX | 20 | Not in Commercial Distribution | 2022-06-08 |
| Primary | 10653405005469 | GS1 | ||||
| Unit of Use | 00653405005462 | GS1 |
Customer Contacts
- Phone
- +1(800)237-0169
- [email protected]