FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Microtek™
DI: 00748426138302
·
Model: Probe Covers PC1292-1
·
Microtek Medical LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Microtek™
- Primary DI
- 00748426138302
- Version / Model
- Probe Covers PC1292-1
- Catalog Number
- PC1292
- Company Name
- Microtek Medical LLC
- Labeler DUNS
- 106908437
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-22
- Public Version
- 2
- Public Version Date
- 2026-02-12
- Public Version Status
- Update
- Public Device Record Key
- b63d5f28-298d-438f-aa23-545b1addea74
- Distribution End Date
- 2026-02-11
Device Description
Intraoperative Probe Cover, 15 cm x 244 cm (6 in x 96 in)
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 |
|---|---|---|---|---|
| PUI | Drape, Surgical, Exempt | General, Plastic Surgery | 878.4370 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44714 | Intraoperative ultrasound imaging transducer cover | A sterile sheath intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gels) and/or to maintain the required hygienic level of an ultrasound imaging system transducer (probe) used intraoperatively, e.g., on internal organs, during an ultrasound examination. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10748426138309 | GS1 | pack | 20 | Not in Commercial Distribution | 2026-02-11 |
| Primary | 00748426138302 | GS1 | ||||
| Package | 20748426138306 | GS1 | case | 1 | Not in Commercial Distribution | 2026-02-11 |
Customer Contacts
- Phone
- 1-800-633-5463
- [email protected]