FDA UDI
In Commercial Distribution
🇺🇸 United States
CMI
DI: H671TS202VT0
·
Model: Velvet Touch Cup
·
UTAH MEDICAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- CMI
- Primary DI
- H671TS202VT0
- Version / Model
- Velvet Touch Cup
- Catalog Number
- TS202VT
- Company Name
- UTAH MEDICAL PRODUCTS, INC.
- Labeler DUNS
- 094651270
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-04
- Public Version
- 1
- Public Version Date
- 2020-06-12
- Public Version Status
- New
- Public Device Record Key
- b11495cf-2285-49dd-8a9c-d0f2d532e470
Device Description
TUBE & ACCESSORY SET - STERILE USED W/CMI VELVET
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
- 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 |
|---|---|---|---|---|
| HDB | Extractor, Vacuum, Fetal | Obstetrics/Gynecology | 884.4340 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46402 | Foetal vacuum extraction system, manual, single-use | An assembly of hand-operated devices designed to facilitate the delivery of a foetus during vaginal childbirth or Caesarean section by enabling traction to be applied to the foetal head by means of a suction cup that is attached to the scalp. It typically consists of a cup with a soft inner liner to prevent tissue damage, a hand-operated pump, and a handle used to apply traction. It is typically used for dystocia, uterine inertia, maternal exhaustion, maternal/foetal distress. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | H671TS202VT0 | HIBCC | ||||
| Package | H671TS202VT1 | HIBCC | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- 800-533-4984
- [email protected]