FDA UDI
In Commercial Distribution
🇺🇸 United States
Sklar®
DI: 10649111294235
·
Model: 67-1020
·
SKLAR CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Sklar®
- Primary DI
- 10649111294235
- Version / Model
- 67-1020
- Company Name
- SKLAR CORPORATION
- Labeler DUNS
- 006966006
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-07
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 79880f93-b683-4f92-b2b7-baaebccc60be
Device Description
Non-Ratcheted finger ring device commonly used for debridement and removing debris from the ear.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
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 |
|---|---|---|---|---|
| 33428 | ENT forceps | A general-purpose ear/nose/throat (ENT) surgical instrument designed to facilitate the grasping, holding, or manipulation of anatomical structures (e.g., trachea, ear) or devices (e.g., cochlear implant electrode array) during ENT procedures. It typically has two main designs: 1) a self-retaining, scissors-like design with ring handles with the working end having a variety of blade designs, e.g., straight, or curved with grooves or serrations to provide grip; and 2) a tweezers-like design (may be a micro/fine instrument) with two conjoined blades with serrated tips at the working end. It is made of high-grade stainless steel. This is a reusable device intended to be sterilized prior to use. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10649111294235 | GS1 |