FDA UDI
In Commercial Distribution
🇺🇸 United States
Iris Forceps
DI: G165SU240900100
·
Model: SU-24-0900-10
·
ELMED INSTRUMENTS(PVT)LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Iris Forceps
- Primary DI
- G165SU240900100
- Version / Model
- SU-24-0900-10
- Catalog Number
- SU-24-0900-10
- Company Name
- ELMED INSTRUMENTS(PVT)LTD.
- Labeler DUNS
- 645680588
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-08
- Public Version
- 1
- Public Version Date
- 2022-09-16
- Public Version Status
- New
- Public Device Record Key
- a4d4b828-9958-4ca4-83c2-13b9aaf385e4
Device Description
Intended Use: Iris Forceps are incredible eye instruments widely used for ophthalmic procedures Packaging: Packaging: Packaging shall be as per customer requirements e.g set of 25 or set of 50.
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 |
|---|---|---|---|---|
| HTD | Forceps | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62673 | Ophthalmic soft-tissue manipulation forceps, tweezers-like, single-use | A sterile, hand-held manual surgical instrument designed to facilitate grasping, manipulation or clamping of, and/or removal of foreign bodies from, ophthalmic soft-tissues (ocular tissues, eyelids), and may be pointed for capsulorhexis. It has a conventional (self-opening) or reverse-action (self-closing) tweezers-like design, with variously designed tips at the working end, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles); it is not probe-like in design (i.e., not cannulated). It is typically made of metal, available in various sizes, and may have carbide inserts at the working end. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G165SU240900100 | HIBCC |