FDA UDI
Not in Commercial Distribution
🇺🇸 United States
NA
DI: 00878953000435
·
Model: 0010-0996
·
AMERICAN MEDICAL SYSTEMS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- NA
- Primary DI
- 00878953000435
- Version / Model
- 0010-0996
- Company Name
- AMERICAN MEDICAL SYSTEMS
- Labeler DUNS
- 796308653
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 4
- Public Version Date
- 2025-07-10
- Public Version Status
- Update
- Public Device Record Key
- 945d0ef5-c299-4422-b5b8-1d6315c6387d
- Distribution End Date
- 2021-06-17
Device Description
Endo Suction/ Microstat 30 Degree Up Bend
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
- 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
- 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 |
|---|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | 878.4810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41707 | Laser beam delivery unit holder | A device designed to be used together with a laser delivery unit to provide support to the delivery unit during the operation of the laser. The holder will help with the positioning of the final laser beam output and increase safety from inadvertent movement which would be undesirable. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00878953000435 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 30 Degree Upward Bend |