FDA UDI
In Commercial Distribution
🇺🇸 United States
GEM COUPLER Microvascular Anastomotic Instrument
DI: 00844735005233
·
Model: GEM2740
·
SYNOVIS MICRO COMPANIES ALLIANCE, INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- GEM COUPLER Microvascular Anastomotic Instrument
- Primary DI
- 00844735005233
- Version / Model
- GEM2740
- Catalog Number
- 519303002010
- 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
- 7
- Public Version Date
- 2023-07-27
- Public Version Status
- Update
- Public Device Record Key
- a1b816b2-f50a-4d44-a995-5eb14ba01141
Device Description
A reusable Instrument designed to hold the GEM COUPLER device and approximate the GEM COUPLER rings during vessel anastomosis
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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| MDM | INSTRUMENT, MANUAL, SURGICAL, GENERAL USE | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61238 | Vascular anastomosis coupling approximator | A non-sterile, hand-held manual surgical instrument designed for use during vascular (including microvascular) anastomosis surgical procedures to hold the rings of a vascular anastomosis coupler while the blood vessel ends are secured to the rings, and then to approximate the rings to create the anastomosis. It is made of metal. This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00844735005233 | GS1 | ||||
| Direct Marking | 00844735006674 | GS1 |
Customer Contacts
- Phone
- +1(800)510-3318
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 20 – 25 Degrees Celsius