FDA UDI
In Commercial Distribution
🇺🇸 United States
OSSEOUS Titanium-Stapes Prosthesis Handling Forceps
DI: 08906039316018
·
Model: EI03
·
EON MEDITECH PRIVATE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- OSSEOUS Titanium-Stapes Prosthesis Handling Forceps
- Primary DI
- 08906039316018
- Version / Model
- EI03
- Company Name
- EON MEDITECH PRIVATE LIMITED
- Labeler DUNS
- 930270428
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-04
- Public Version
- 1
- Public Version Date
- 2024-07-12
- Public Version Status
- New
- Public Device Record Key
- 25481f75-3898-4be0-86c7-1ca2eab6d280
Device Description
It is used to catching up the hook of prosthesis to handling prosthesis during surgery.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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 |
|---|---|---|---|---|
| KAE | Forceps, Ent | Ear, Nose, Throat | 874.4420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11791 | Dressing/utility forceps, scissors-like, reusable | A hand-held manual instrument designed primarily for non-dedicated grasping of devices, sponges and/or dressings during a procedure; it is neither intended for tissue manipulation nor endoscopic use. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 08906039318029 | GS1 | Laminated Box | 1 | In Commercial Distribution | |
| Primary | 08906039316018 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 25 Degrees Celsius