FDA UDI
In Commercial Distribution
🇺🇸 United States
PILLING
DI: 14026704806963
·
Model: IPN021391
·
TELEFLEX INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- PILLING
- Primary DI
- 14026704806963
- Version / Model
- IPN021391
- Catalog Number
- P27172
- Company Name
- TELEFLEX INCORPORATED
- Labeler DUNS
- 002348191
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-08
- Public Version
- 1
- Public Version Date
- 2022-12-16
- Public Version Status
- New
- Public Device Record Key
- 10dc60c8-d950-4d3b-8c5a-7af8f5a6cc0f
Device Description
CHISEL BALLENGER V-SHAPED EDGE 2MM WIDE
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
- 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 |
|---|---|---|---|---|
| KAN | CHISEL, NASAL | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16400 | Middle ear chisel | A single-blade bevelled surgical instrument intended for use in cutting or contouring the bones of the middle ear, otological microsurgery, stapedotomy, and related ear/nose/throat (ENT) surgery. It is hand-held by the surgeon who will use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp and can be either straight or angled. It is typically a one-piece instrument 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 |
|---|---|---|---|---|---|---|
| Direct Marking | 54026704806961 | GS1 | ||||
| Primary | 14026704806963 | GS1 |
Customer Contacts
- Phone
- +1(919)544-8000
- [email protected]