FDA UDI
In Commercial Distribution
🇺🇸 United States
MICROTEK
DI: 00748426006359
·
Model: 1
·
Microtek Medical LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- MICROTEK
- Primary DI
- 00748426006359
- Version / Model
- 1
- Company Name
- Microtek Medical LLC
- Labeler DUNS
- 106908437
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-11-04
- Public Version
- 5
- Public Version Date
- 2025-02-05
- Public Version Status
- Update
- Public Device Record Key
- 5787023f-7b58-4488-b928-d65ff3f8ede3
Device Description
UNDER BUTTOCKS DRAPE, 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
- Radiation Sterilization
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 |
|---|---|---|---|---|
| 42559 | Urological surgical drape | A protective covering made of natural or synthetic materials, or both, designed to isolate a urological procedure site from contamination (e.g., microbial, substance). It will typically be shaped for this purpose and may be used for cystoscopy, transurethral resection (TUR), or percutaneous nephrostolithotomy (PCNL). This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50748426006354 | GS1 | 25 | In Commercial Distribution | ||
| Primary | 00748426006359 | GS1 |
Customer Contacts
- Phone
- +1(800)824-3027
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store under normal warehouse conditions.