FDA UDI
In Commercial Distribution
🇺🇸 United States
GEM Microvascular Anastomotic COUPLER System
DI: 00844735005226
·
Model: GEM 2741CC
·
SYNOVIS MICRO COMPANIES ALLIANCE, INC
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- GEM Microvascular Anastomotic COUPLER System
- Primary DI
- 00844735005226
- Version / Model
- GEM 2741CC
- Catalog Number
- 519301006010
- 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
- 2016-09-24
- Public Version
- 8
- Public Version Date
- 2023-07-27
- Public Version Status
- Update
- Public Device Record Key
- 62e5fae7-e47d-4004-8735-1686ac4e165c
Device Description
The GEM Microvascular Anastomotic COUPLER System consists of a reusable Anastomotic Instrument, two reusable COUPLER Forceps, a reusable Double-Ended Vessel Measuring Gauge, and reusable Microvascular Anastomotic COUPLER Sterilization Tray.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KCT | Sterilization wrap containers, trays, cassettes & other accessories | General Hospital | 880.6850 | 2 |
| MDM | INSTRUMENT, MANUAL, SURGICAL, GENERAL USE | General, Plastic Surgery | 878.4800 | 1 |
| HTD | FORCEPS | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61239 | Vascular anastomosis coupling kit, reusable | A collection of devices intended to be used to implant a vascular anastomosis coupler [not included] to join vascular (including microvascular) structures by the coupling of two ring-shaped components. It consists of two or more items typically amongst: a coupling approximator for holding the rings of the coupler during approximation, a dedicated forceps/everter for placing the ends of the blood vessel over the pins of the coupler, a vessel diameter guide (sizer), and a sterilization tray. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00844735005226 | GS1 |
Customer Contacts
- Phone
- +1(800)510-3318
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K071783 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 20 – 25 Degrees Celsius