FDA UDI
In Commercial Distribution
🇺🇸 United States
Single Use Silc Cup with tubing (Obstetrics)
DI: 07612367009355
·
Model: 077.0791
·
Medela AG
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Single Use Silc Cup with tubing (Obstetrics)
- Primary DI
- 07612367009355
- Version / Model
- 077.0791
- Company Name
- Medela AG
- Labeler DUNS
- 488293218
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-05-13
- Public Version
- 4
- Public Version Date
- 2022-05-31
- Public Version Status
- Update
- Public Device Record Key
- e3df1593-519d-4edf-b252-33683949b12d
Device Description
Single Use Silc Cup with tubing (Obstetrics) The Single Use Silc Cup is intended to assist a clinician in the vacuum delivery of an infant during childbirth. The device is single use.
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
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | General, Plastic Surgery | 878.4780 | 2 |
| HDB | Extractor, Vacuum, Fetal | Obstetrics/Gynecology | 884.4340 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37792 | Foetal vacuum extraction system cup, single-use | A suction cap intended to be applied to the scalp of a foetus to facilitate vaginal or Caesarean section delivery by traction. It typically has a soft liner to prevent tissue damage, a connection to the vacuum source, a handgrip for the clinician to apply traction, and may include a vacuum release valve and fluid retention trap. Suction may be provided by an electrically-powered suction pump, the hospital central vacuum system, or a hand-operated vacuum pump. It is typically used for dystocia, uterine inertia, maternal exhaustion, or 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 | 07612367009355 | GS1 | ||||
| Package | 07612367037815 | GS1 | 25 | Not in Commercial Distribution | 2022-05-31 | |
| Package | 07612367077088 | GS1 | 5 | In Commercial Distribution |
Customer Contacts
- Phone
- +1-877-735-1626
- [email protected]