FDA UDI
In Commercial Distribution
🇺🇸 United States
GEM Microvascular Anastomotic COUPLER
DI: 00844735002706
·
Model: GEM2755
·
SYNOVIS MICRO COMPANIES ALLIANCE, INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- GEM Microvascular Anastomotic COUPLER
- Primary DI
- 00844735002706
- Version / Model
- GEM2755
- Catalog Number
- 512100350060
- Company Name
- SYNOVIS MICRO COMPANIES ALLIANCE, INC
- Labeler DUNS
- 031284586
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-08
- Public Version
- 4
- Public Version Date
- 2023-07-20
- Public Version Status
- Update
- Public Device Record Key
- 2cf32b03-82c2-46bd-af85-d6811449a732
Device Description
The GEM Microvascular Anastomotic COUPLER Device rings are made of polyethylene and surgical grade stainless steel pins. A protective cover and jaw assembly protect the rings and allow for easy loading onto the Anastomotic Instrument. Both the protective cover and jaw assembly are disposable. The GEM Microvascular Anastomotic COUPLER Device is single-use and available in various sizes
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
- 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 |
|---|---|---|---|---|
| MVR | Device,anastomotic,microvascular | General, Plastic Surgery | 878.4300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 18137 | Vascular anastomosis coupler, basic | An implantable device intended to be used to permanently join vascular structures (blood vessels) through the coupling of two ring-shaped components that are inserted into the ends of the vessels to be attached. It is also used in microvascular surgery. This device is made of a substance or material that cannot be chemically degraded or absorbed via natural body processes (e.g., stainless steel). | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10844735002703 | GS1 | CASE | 6 | In Commercial Distribution | |
| Primary | 00844735002706 | GS1 |
Customer Contacts
- Phone
- +1(800)933-0303
- [email protected]