FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 00748426145027
·
Model: Equipment Drapes
·
Microtek Medical LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- NA
- Primary DI
- 00748426145027
- Version / Model
- Equipment Drapes
- Catalog Number
- HC3260
- Company Name
- Microtek Medical LLC
- Labeler DUNS
- 106908437
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-02-05
- Public Version
- 1
- Public Version Date
- 2026-02-13
- Public Version Status
- New
- Public Device Record Key
- 5a8ea33d-fc67-4cab-80d4-4c8cc7c8c320
Device Description
Universal Handle Covers, 15 cm x 36 cm
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
- Yes
- 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 |
|---|---|---|---|---|
| FTA | Light, Surgical, Accessories | General, Plastic Surgery | 878.4580 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44977 | Medical equipment handle cover, single-use | A device designed specifically to cover the handle of a piece of medical equipment (e.g., operating light) to provide a physical sterile barrier between the handle and the hand of a healthcare professional, e.g., during a surgical procedure. It is typically a polymer device designed for attachment to a handle and may in addition provide grip for improved manipulation of the handle; it is not designed to cover other equipment components. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10748426145024 | GS1 | pack | 20 | In Commercial Distribution | |
| Primary | 00748426145027 | GS1 | ||||
| Package | 20748426145021 | GS1 | case | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- 1(800)633-5463
- [email protected]