FDA UDI
In Commercial Distribution
🇺🇸 United States
Symmetry GARRETT
DI: 00887482085233
·
Model: 55-7002X
·
SYMMETRY SURGICAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Symmetry GARRETT
- Primary DI
- 00887482085233
- Version / Model
- 55-7002X
- Catalog Number
- 55-7002X
- Company Name
- SYMMETRY SURGICAL INC.
- Labeler DUNS
- 079641356
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 6282e266-119a-4bc1-a6c6-65256df5619b
- Distribution End Date
- 9999-01-01
Device Description
Dilator Holder for 5 1/2" Dilator
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| DWP | Dilator, Vessel, Surgical | Cardiovascular | 870.4475 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11266 | Fixed-diameter cervical dilator, reusable | A rod-like, solid surgical instrument designed to dilate the cervical canal after its insertion through the cervical os. Commonly known as a uterine dilator, it is typically made of metal or plastic material and has a tapered, rounded distal tip. It may have one diameter or two different size diameters, one at each end of the instrument. The device is typically available in a set of graduated sizes that are applied in succession. It is used to allow the passage of a curette or other instruments into the uterus and/or enlarge the uterus prior to surgical intervention by pressing on the inner walls of the uterus. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00887482085233 | GS1 |