FDA UDI
In Commercial Distribution
🇺🇸 United States
MICROTEK
DI: 00748426034666
·
Model: 1
·
Microtek Medical Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- MICROTEK
- Primary DI
- 00748426034666
- 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
- 4
- Public Version Date
- 2023-03-22
- Public Version Status
- Update
- Public Device Record Key
- cbfa3d64-54dc-4366-9091-be15ff1bba9a
Device Description
INCISE DRAPE, 36 X 36, FEATURING MICROBAN, LATEX FREE, 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 |
|---|---|---|---|---|
| 16038 | Implantable pulse generator mesh bag, non-bioabsorbable | An implantable woven/knitted or porous bag made from a non-bioabsorbable synthetic polymer(s) intended to envelop an implantable pulse generator (IPG) (e.g., cardiac pacemaker/defibrillator) to stabilize the implant in the subcutaneous pocket in which it is implanted; it does not contain an antimicrobial agent. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50748426034661 | GS1 | 1 | In Commercial Distribution | ||
| Package | 30748426034667 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 00748426034666 | GS1 |
Customer Contacts
- Phone
- +1(800)824-3027
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store under normal warehouse conditions.