FDA UDI
In Commercial Distribution
🇺🇸 United States
MICROTEK
DI: 00748426063567
·
Model: 1
·
Microtek Medical Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- MICROTEK
- Primary DI
- 00748426063567
- 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
- 2016-11-04
- Public Version
- 3
- Public Version Date
- 2023-03-22
- Public Version Status
- Update
- Public Device Record Key
- 4fa363d5-b20c-4718-8d0e-5653119bc2df
Device Description
ARMBOARD DRAPE, 10"" X 36"", 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 |
|---|---|---|---|---|
| 44288 | Armrest/arm support cover, sterile | A sterile device designed as an outer covering and used for the protection of an arm supporting device, e.g., an armrest, armboard, or arm posturing device, against unhygienic conditions. It will typically be made of thin, shaped, plastic material which creates a physical barrier between the patient's arm and the arm holder or arm supporting device. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30748426063568 | GS1 | 36 | In Commercial Distribution | ||
| Primary | 00748426063567 | GS1 | ||||
| Package | 50748426063562 | GS1 | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)824-3027
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store under normal warehouse conditions.