FDA UDI
In Commercial Distribution
🇺🇸 United States
MICROTEK
DI: 00748426108206
·
Model: 1
·
Microtek Medical Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- MICROTEK
- Primary DI
- 00748426108206
- Version / Model
- 1
- Company Name
- Microtek Medical Inc.
- Labeler DUNS
- 106908437
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-11-16
- Public Version
- 3
- Public Version Date
- 2023-03-22
- Public Version Status
- Update
- Public Device Record Key
- ca1d86bd-2ebf-4ebf-8d84-59d758c17de4
Device Description
SIEMENS FLEXIBLE HOSE COVER FOR ZEEGO, 1-EACH
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KKX | Drape, surgical | General, Plastic Surgery | 878.4370 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45021 | Instrument/equipment drape, single-use, sterile | A sterile device made of natural and/or synthetic flexible materials intended to be used as a non-dedicated protective covering for various surgical and/or non-surgical instruments/equipment [e.g., surgical tray, operating room (OR) equipment table, endoscope and endoscopic instruments, surgical cameras and lasers], to provide a barrier against cross-contamination in various clinical settings. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50748426108201 | GS1 | 20 | In Commercial Distribution | ||
| Primary | 00748426108206 | GS1 |
Customer Contacts
- Phone
- +1(800)824-3027
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store under normal warehouse conditions.