FDA UDI
In Commercial Distribution
🇺🇸 United States
PITANGUY ABDOMINAL MARKING FORCEPS
DI: 00192896094765
·
Model: 475-849
·
SONTEC INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PITANGUY ABDOMINAL MARKING FORCEPS
- Primary DI
- 00192896094765
- Version / Model
- 475-849
- Catalog Number
- 475-849
- Company Name
- SONTEC INSTRUMENTS, INC.
- Labeler DUNS
- 040729840
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-03-07
- Public Version
- 1
- Public Version Date
- 2019-03-15
- Public Version Status
- New
- Public Device Record Key
- 8292213e-54d1-4bf1-9f78-9a7a302bcc12
Device Description
PITANGUY ABDOMINAL MARKING 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
- Yes
- 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 |
|---|---|---|---|---|
| KAE | FORCEPS, ENT | Ear, Nose, Throat | 874.4420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46755 | Mastoid rongeur | A surgical instrument designed to remove hard or tough tissues (e.g., bone or cartilage) around the mastoid process (the large projection of the temporal bone of the skull found immediately behind each ear) by applying a biting/cutting action during ear/nose/throat (ENT) surgery. It is has a forceps or pliers-like design terminating at the distal end with sharp-edged, scoop-shaped, narrow jaws attached to strong, sprung (self-opening), pivoted handles that, when squeezed together, close the jaws to bite (cut) through the mastoid tissue. It is available in various sizes and is made of high-grade stainless steel and designed to withstand the forces which are applied. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00192896094765 | GS1 |
Customer Contacts
- Phone
- +1(800) 821-7496
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 12.5 | Inch |