FDA UDI
In Commercial Distribution
🇺🇸 United States
RETRACTOR RING
DI: 00192896080959
·
Model: 516-856L
·
SONTEC INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- RETRACTOR RING
- Primary DI
- 00192896080959
- Version / Model
- 516-856L
- Catalog Number
- 516-856L
- Company Name
- SONTEC INSTRUMENTS, INC.
- Labeler DUNS
- 040729840
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-20
- Public Version
- 1
- Public Version Date
- 2018-10-22
- Public Version Status
- New
- Public Device Record Key
- f21bdd61-b937-49c3-a4c2-aeb46e06a633
Device Description
RETRACTOR RING SOLID LARGE ROUND RING
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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- ["Moist Heat or Steam Sterilization", "Dry Heat Sterilization"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HXP | INSTRUMENT, BENDING OR CONTOURING | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32098 | Laparotomy ring | A surgical instrument designed in the shape of a circular band that is set into the abdominal wall to hold open an incision during surgery on the abdominal organs. It functions as a fixed-length access retractor or wound retractor and is used in procedures where entry of the surgeon's hand into the abdominal cavity may facilitate the procedure, and for the extraction of large specimens. This device is used in colorectal, urological, gynaecological, and general surgical procedures. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00192896080959 | GS1 |
Customer Contacts
- Phone
- +1(800) 821-7496
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Lumen/Inner Diameter | 12.5 | Inch |