AccessGUDID - DEVICE: NA (04715309129449)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: RD003-W
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PANPAC MEDICAL CORPORATION

Primary DI Number: 04715309129449
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 657528899 *Terms of Use

Device Description: The ETO Sterilized Curette is used to obtain a sample of differentiated endometrial tissue. The Curette is a 3mm (O.D.) endometrial suction curette with a Randall-like cutting edge at its distal end and packaged with a twist-and-lock syringe. The syringe provides the vacuum or suction during the procedure. The Curette is sterile unless the package is opened or damaged. It is designed for single patient use only.

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
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?
11531	Endometrial biopsy kit	A collection of sterile devices designed for the collection of a tissue sample taken from the lining of the uterus (endometrium). It typically includes an aspirating curette, a specimen container and other materials. It is used in the study of endometrial cytology (cells). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HHK	Curette, Suction, Endometrial (And Accessories)

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e25f16c4-4124-4436-9e3a-afae5f35afb4
Public Version Date: November 07, 2022
Public Version Number: 5
DI Record Publish Date: August 15, 2016