AccessGUDID - DEVICE: OPS A.R.T. OF C.C.D. ® WITHOUT VALVE (03700111400917)

GUDID

Device Identifier (DI) Information

Brand Name: OPS A.R.T. OF C.C.D. ® WITHOUT VALVE
Version or Model: OPS A.R.T. OF C.C.D. ® WITHOUT VALVE
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1313101
Company Name: LABORATOIRE CCD

Primary DI Number: 03700111400917
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 381633924 *Terms of Use

Device Description: Set for oocyte retrieval

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):	No
Over the Counter (OTC):	No
Kit:	Yes
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?
45676	IVF oocyte aspiration needle, single-use	A sterile, sharp bevel-edged, hollow tubular metal instrument specifically designed to penetrate ovarian follicles and aspirate oocytes (eggs) typically during the harvesting phase of an in vitro fertilization (IVF) procedure. The device may include aspiration tubing attached to its proximal end. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MQE	NEEDLE, ASSISTED REPRODUCTION

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Special Storage Condition, Specify: -The product must not be used in the event of damaged, or open primary packaging before the medical procedure. -Store away from direct sunlight. -Store in a dry place.

Clinically Relevant Size

[?]

Size Type Text
Needle Gauge: 17 Gauge
Shaft Length: 30 Centimeter

Device Record Status

Public Device Record Key: 01f2d261-168c-4117-9f91-11fc000571fd
Public Version Date: December 13, 2023
Public Version Number: 1
DI Record Publish Date: December 05, 2023