FDA UDI
In Commercial Distribution
🇺🇸 United States
Tissue Forceps
DI: G165SU80179110
·
Model: SU-8-0179-11
·
ELMED INSTRUMENTS(PVT)LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Tissue Forceps
- Primary DI
- G165SU80179110
- Version / Model
- SU-8-0179-11
- Catalog Number
- SU-8-0179-11
- 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
- 4fc124b4-9653-4712-8e4a-b5682521bfa1
Device Description
Intended Use: Tissue forceps are used to: manipulate tissues. support tissues while making incisions, and suturing. retract tissues to improve exposure. 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 |
|---|---|---|---|---|
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62479 | Surgical soft-tissue manipulation forceps, tweezers-like, single-use | A hand-held, manual, open-surgery instrument designed to facilitate grasping and manipulation of soft-tissues. It has a tweezers-like design (may be a micro/fine instrument) 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 available in various sizes, and may have carbide inserts at the working end. It is not an electrosurgical device and not dedicated to ophthalmic surgery. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G165SU80179110 | HIBCC |