FDA UDI
In Commercial Distribution
🇺🇸 United States
Malosa Medical
DI: 35055186207565
·
Model: MMSU1260S
·
Beaver-Visitec International, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
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Basic Information
- Brand Name
- Malosa Medical
- Primary DI
- 35055186207565
- Version / Model
- MMSU1260S
- Catalog Number
- MMSU1260S
- Company Name
- Beaver-Visitec International, Inc.
- Labeler DUNS
- 001406024
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2022-02-19
- Public Version
- 1
- Public Version Date
- 2022-02-28
- Public Version Status
- New
- Public Device Record Key
- 67e1a515-e87e-4aec-b293-c870a77f1a3c
Device Description
Alphonso Paediatric Speculum
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
- 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 |
|---|---|---|---|---|
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59037 | Ocular hook/spatula/manipulator, single-use | A hand-held, blunt, manual ophthalmic surgical instrument intended for manipulation/retraction of intraocular structures, lens nucleus splitting/manipulation, removal of foreign bodies in the eye, corneal manipulation (e.g., LASIK flap lifting), and/or in situ intraocular lens (IOL) manipulation/implantation; it is neither intended to cut tissue nor hook muscles. It may be of single- or double-ended design with a working end(s) designed as a hook, spatula, or other manipulator (often Y-shaped); it is not a curette, loop, trabeculotome, spoon, or inner limiting membrane (ILM) scraper. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 05055186207564 | GS1 | ||||
| Primary | 35055186207565 | GS1 |
Customer Contacts
- Phone
- 18669068080
- [email protected]