FDA UDI
In Commercial Distribution
🇺🇸 United States
MILLS OSCHNER PLAQUE REMOVER FORCEPS
DI: 00192896087637
·
Model: 2700-0-05
·
SONTEC INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MILLS OSCHNER PLAQUE REMOVER FORCEPS
- Primary DI
- 00192896087637
- Version / Model
- 2700-0-05
- Catalog Number
- 2700-0-05
- Company Name
- SONTEC INSTRUMENTS, INC.
- Labeler DUNS
- 040729840
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-21
- Public Version
- 1
- Public Version Date
- 2018-10-22
- Public Version Status
- New
- Public Device Record Key
- a9d8a8a6-847a-4e01-a3d6-c56e38317cdf
Device Description
MILLS OSCHNER PLAQUE REMOVER FORCEPS
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
- ["Dry Heat Sterilization", "Moist Heat or Steam Sterilization"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GAI | STRIPPER, VEIN, REUSABLE | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35165 | Endarterectomy loop | A hand-held manual surgical instrument intended to be used to grip and excise atherosclerotic deposits (i.e., thickened atheromatous tunica intima) from the lumen of an artery (i.e., endarterectomy). It will typically consist of a slender handle onto which a piece of flexible wire that ends in a small loop is attached or be used together with an endarterectomy loop puller. It is typically inserted percutaneously under radiographic guidance. It is made of high-grade stainless steel. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00192896087637 | GS1 |
Customer Contacts
- Phone
- +1(800) 821-7496
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 6 | Inch |