FDA UDI
In Commercial Distribution
🇺🇸 United States
Symmetry Surgical®
DI: 00887482049945
·
Model: 55-8681
·
SYMMETRY SURGICAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Symmetry Surgical®
- Primary DI
- 00887482049945
- Version / Model
- 55-8681
- Catalog Number
- 55-8681
- Company Name
- SYMMETRY SURGICAL INC.
- Labeler DUNS
- 079641356
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-25
- Public Version
- 1
- Public Version Date
- 2018-10-26
- Public Version Status
- New
- Public Device Record Key
- c3e65cd7-832b-49fa-849f-dc86674830ca
- Distribution End Date
- 9999-01-01
Device Description
Symmetry® Valvulotome, Antegrade, 6 1/4 in
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
- Yes
- 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 |
|---|---|---|---|---|
| MGZ | Valvulotome | Cardiovascular | 870.4885 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 14339 | Valvulotome | A hand-held manual surgical instrument designed for cutting an anatomical valve or valves in situ (e.g., to slit a heart valve or to cut the valves within a vein to allow blood flow in the opposite direction). It is typically a flexible, plastic-coated metal shaft with a proximal handle and an extremely sharp cutting edge at the distal tip (e.g., the distal tip may terminate in a blade which is curved at 90 degrees to the shaft, or an assembly of several thin helicoidal blades that are rotated). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00887482049945 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K022823 | 000 |