FDA UDI
In Commercial Distribution
🇺🇸 United States
23ga Dex Tips™ Pincer Style ILM Forceps
DI: 00817489023136
·
Model: CVF4018-23
·
KATALYST SURGICAL LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- 23ga Dex Tips™ Pincer Style ILM Forceps
- Primary DI
- 00817489023136
- Version / Model
- CVF4018-23
- Company Name
- KATALYST SURGICAL LLC
- Labeler DUNS
- 007883297
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-11
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 2678d7cd-d78e-43fe-8b79-61e00c83cf10
Device Description
Box of 5, 23ga Dex Tips™ Pincer Style ILM Forceps
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HNR | Forceps, Ophthalmic | Ophthalmic | 886.4350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46710 | Ophthalmic tissue forceps, single-use | A hand-held ophthalmic surgical instrument used to grasp, manipulate, compress, pull, or join eye and/or surrounding tissues during a surgical intervention. It is typically: 1) a one-piece instrument with a tweezers-like design having two conjoined blades with serrated tips at the working end; or 2) an instrument tip, with grasping blades at the distal end, that is inserted into a dedicated handle through which the blades are operated. It is typically made of high-grade stainless steel and plastic materials, and is available in various sizes. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817489023136 | GS1 |