FDA UDI
In Commercial Distribution
🇺🇸 United States
SMARTGUARD MICRO100
DI: 10845854033180
·
Model: 00137511200
·
Conmed Corporation
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
30
Basic Information
- Brand Name
- SMARTGUARD MICRO100
- Primary DI
- 10845854033180
- Version / Model
- 00137511200
- Catalog Number
- 1375-112
- Company Name
- Conmed Corporation
- Labeler DUNS
- 071595540
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 30
- Record Status
- Published
- Publish Date
- 2020-09-24
- Public Version
- 3
- Public Version Date
- 2023-05-25
- Public Version Status
- Update
- Public Device Record Key
- 2227e660-8c15-4239-a415-a784e349fba2
Device Description
SMARTGUARD MICRO 100
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
- No
- 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 |
|---|---|---|---|---|
| GET | MOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED | General, Plastic Surgery | 878.4820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34004 | Surgical instrument guard, reusable | A device designed to be applied to a variety of surgical or invasive instruments to protect the instrument and/or its operator and/or the patient from injury, distortion, or damage during an procedure, handling, and/or storage. It is typically made of stainless steel or plastic materials. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20845854033187 | GS1 | CARTON | 30 | In Commercial Distribution | |
| Primary | 10845854033180 | GS1 | ||||
| Unit of Use | 00845854033183 | GS1 |
Customer Contacts
- Phone
- +1(866)426-6633
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- High: 40 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- High: 104 Degrees Fahrenheit