FDA UDI
Not in Commercial Distribution
🇺🇸 United States
T-Shaped Surgi Transducer Cover
DI: 10841436106006
·
Model: 645-058
·
CIVCO MEDICAL INSTRUMENTS CO., INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- T-Shaped Surgi Transducer Cover
- Primary DI
- 10841436106006
- Version / Model
- 645-058
- Catalog Number
- 645-058
- Company Name
- CIVCO MEDICAL INSTRUMENTS CO., INC.
- Labeler DUNS
- 134614411
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-08-22
- Public Version
- 6
- Public Version Date
- 2022-11-22
- Public Version Status
- Update
- Public Device Record Key
- a10db6e4-fa6c-4701-9e19-ed3eee5a7ea4
- Distribution End Date
- 2022-09-30
Device Description
Sterile (15.3 x 244cm) polyethylene accordion-folded cover with attached form-fitting latex tip
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| 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 | 00841436106009 | GS1 | 12 | Not in Commercial Distribution | 2022-09-30 | |
| Primary | 10841436106006 | GS1 |
Customer Contacts
- Phone
- +1(319)248-6502
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K943393 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 98 | Inch | |
| Width | 5.9 | Inch |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Away from Sunlight
- Type
- Storage Environment Temperature
- Temperature Range
- 52 – 85 Degrees Fahrenheit