FDA UDI
Not in Commercial Distribution
🇺🇸 United States
ERGONOMIC HIGHLY RIGID PLASTIC RING HANDLE
DI: B09929010980
·
Model: 2901-098
·
SONTEC INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ERGONOMIC HIGHLY RIGID PLASTIC RING HANDLE
- Primary DI
- B09929010980
- Version / Model
- 2901-098
- Company Name
- SONTEC INSTRUMENTS, INC.
- Labeler DUNS
- 040729840
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-19
- Public Version
- 6
- Public Version Date
- 2025-11-24
- Public Version Status
- Update
- Public Device Record Key
- 8bccbec8-e45f-4cd8-8e69-2bbe0c2a3608
- Distribution End Date
- 2018-09-22
Device Description
ERGONOMIC HIGHLY RIGID PLASTIC RING HANDLE WITH RATCHET/RATCHET ACTIVATING-DEACTIVATING KEY/ ROTATION MODULE AND HIGH FREQUENCY CONNECTION
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
- No
- 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 |
|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32043 | Laparoscopic surgical procedure kit, non-medicated, reusable | A collection of various laparoscopic and surgical instruments (e.g., access cannulae, irrigation/aspiration cannula, forceps), dressings, and additional materials intended to be used specifically to perform a laparoscopic surgical procedure. It does not contain pharmaceuticals. It may be referred to as a procedure tray. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B09929010980 | HIBCC |
Customer Contacts
- Phone
- 800-821-7496
- [email protected]
Premarket Submissions
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | FOR Ø3mm, Ø5mm & Ø10mm TUBE SHAFT INSTRUMENTS |