FDA UDI
In Commercial Distribution
🇺🇸 United States
Alligator Forceps
DI: G165SU270164090
·
Model: SU-27-0164-09
·
ELMED INSTRUMENTS(PVT)LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Alligator Forceps
- Primary DI
- G165SU270164090
- Version / Model
- SU-27-0164-09
- Catalog Number
- SU-27-0164-09
- 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
- 388c68c9-a14d-4ea7-9311-2ae85a9eddd9
Device Description
Intended Use: Alligator Forceps are an ENT instrument commonly used in myringotomy procedures to insert or remove tubes or dressings and packing 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 |
|---|---|---|---|---|
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61481 | Open-surgery biopsy forceps, single-use | A hand-held manual surgical instrument designed to obtain soft-tissue biopsy specimens from an open surgical wound or from within/near a large natural orifice (e.g., vagina, rectum) for histopathological examination; it is not intended for endoscopic or catheterized access. It is a metallic forceps-like instrument with a distal mechanism designed to bite/punch the biopsy sample and hold it for extraction when the handles are squeezed together. It is not designed for cutting bone (i.e., not a rongeur). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G165SU270164090 | HIBCC |