FDA UDI
In Commercial Distribution
🇺🇸 United States
Proficient Surgical
DI: 06975424198722
·
Model: PS2037
·
EXACT MEDICAL MANUFACTURING, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Proficient Surgical
- Primary DI
- 06975424198722
- Version / Model
- PS2037
- Company Name
- EXACT MEDICAL MANUFACTURING, INC.
- Labeler DUNS
- 014464314
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-11
- Public Version
- 1
- Public Version Date
- 2026-03-19
- Public Version Status
- New
- Public Device Record Key
- 68740baf-184a-4a90-920a-0ee6e4e612cd
Device Description
INTRAOPERATIVE PROBE DRAPE, 5” X 96"
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
- Yes
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | 892.1570 | 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 | 16975424198729 | GS1 | Inner Case | 20 | In Commercial Distribution | |
| Primary | 06975424198722 | GS1 | ||||
| Package | 26975424198726 | GS1 | Case | 60 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K222460 | 000 |