AccessGUDID - DEVICE: Soft-ECC-S (00860275000330)

GUDID

Device Identifier (DI) Information

Brand Name: Soft-ECC-S
Version or Model: SFT-2100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SFT-2100
Company Name: HISTOLOGICS, LLC

Primary DI Number: 00860275000330
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 023001257 *Terms of Use

Device Description: Endocervical curette system (small size) for tissue collection, storage, and transport.

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?
57938	Endocervical specimen collection kit	A collection of devices intended to be used for the collection, preservation, and transport of cellular and/or other material collected from the endocervix for culture, analysis, and/or other investigation. It typically includes a swab, brush, spatula, and/or other collection devices and a transport container (with or without additives). This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HCY	Curette, Uterine

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: 7dab76c1-aef9-412c-9c0f-53036017f614
Public Version Date: November 18, 2019
Public Version Number: 1
DI Record Publish Date: November 10, 2019