FDA UDI
In Commercial Distribution
🇺🇸 United States
Derf Needle Holder
DI: G165SU130184120
·
Model: SU-13-0184-12
·
ELMED INSTRUMENTS(PVT)LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Derf Needle Holder
- Primary DI
- G165SU130184120
- Version / Model
- SU-13-0184-12
- Catalog Number
- SU-13-0184-12
- Company Name
- ELMED INSTRUMENTS(PVT)LTD.
- Labeler DUNS
- 645680588
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-09
- Public Version
- 1
- Public Version Date
- 2022-09-19
- Public Version Status
- New
- Public Device Record Key
- 5680f536-25bb-4f92-aaae-f559670bea73
Device Description
Intended Use: Derf Needle Holders help surgeons to handle and insert suture needles during wound closures. Packaging: Packaging shall be as per customer requirements e.g set of 25 and 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 |
|---|---|---|---|---|
| FHQ | Holder, Needle, Gastroenterologic | Gastroenterology, Urology | 876.4730 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47568 | Suturing needle holder, single-use | A hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It has short serrated jaws at the distal end to provide better grip of the needle, and is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G165SU130184120 | HIBCC |