FDA UDI
Not in Commercial Distribution
🇺🇸 United States
MONDEAL
DI: 04050435041334
·
Model: 27-17588
·
MONDEAL Medical Systems GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MONDEAL
- Primary DI
- 04050435041334
- Version / Model
- 27-17588
- Catalog Number
- 27-17588
- Company Name
- MONDEAL Medical Systems GmbH
- Labeler DUNS
- 312546955
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-06-26
- Public Version
- 7
- Public Version Date
- 2022-03-22
- Public Version Status
- Update
- Public Device Record Key
- d6cfd31f-63f4-4063-b1f3-70d3ab0daff0
- Distribution End Date
- 2018-12-31
Device Description
Bone holding forceps serrated pointed 13 cm
Device Characteristics
- Single Use
- No
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42500 | Dressing/utility forceps, tweezers-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 typically has a tweezers-like design with two blades joined at the proximal (non-working) end with variously designed tips at the working end. It is made of metal and/or plastic materials and is available in various sizes. 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 |
|---|---|---|---|---|---|---|
| Primary | 04050435041334 | GS1 |
Customer Contacts
- Phone
- +1904-641-7746
- [email protected]