FDA UDI
In Commercial Distribution
🇺🇸 United States
Amsel Occluder Device
DI: 00857774006000
·
Model: 100-200
·
AMSEL MEDICAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- Amsel Occluder Device
- Primary DI
- 00857774006000
- Version / Model
- 100-200
- Catalog Number
- 100-200
- Company Name
- AMSEL MEDICAL CORPORATION
- Labeler DUNS
- 078410514
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-26
- Public Version
- 5
- Public Version Date
- 2021-05-19
- Public Version Status
- Update
- Public Device Record Key
- 417e7f0c-8fb7-46a6-851a-9f010ab26196
Device Description
The Amsel Occluder Device is designed to easily and securely close blood vessels (veins or arteries as well as hollow ducts) during surgical procedures. It is intended for use in open general surgery procedures on tubular structures or blood vessels (arteries and veins) wherever a metal ligating clip is indicated and within the size range of 2.0mm to 7.0mm diameter.
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
- MR Conditional
- 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 |
|---|---|---|---|---|
| FZP | Clip, Implantable | General, Plastic Surgery | 878.4300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35649 | Ligation clip, metallic | A metallic, non-bioabsorbable clasp designed to be implanted around a blood vessel, lymphatic vessel, other tubular anatomy or a tissue bundle, for permanent occlusion. It may be used for ligation in open and endoscopic (e.g., laparoscopic) surgeries; a dedicated, disposable clip applier may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00857774006000 | GS1 | ||||
| Package | 10857774006007 | GS1 | Single Box | 1 | In Commercial Distribution | |
| Package | 20857774006004 | GS1 | Box of 6 | 6 | In Commercial Distribution | |
| Package | 30857774006001 | GS1 | Master Box | 3 | In Commercial Distribution |
Customer Contacts
- Phone
- (857)777-0040
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K140932 | 000 |