AccessGUDID - DEVICE: Single Use Silc Cup with tubing (Obstetrics) (07612367009355)

GUDID

Device Identifier (DI) Information

Brand Name: Single Use Silc Cup with tubing (Obstetrics)
Version or Model: 077.0791
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Medela AG

Primary DI Number: 07612367009355
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 488293218 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BTA	Pump, Portable, Aspiration (Manual Or Powered)
HDB	Extractor, Vacuum, Fetal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K041579	000
K130123	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e3df1593-519d-4edf-b252-33683949b12d
Public Version Date: May 31, 2022
Public Version Number: 4
DI Record Publish Date: May 13, 2019