AccessGUDID - DEVICE: Soviflex (B79510010)

GUDID

Device Identifier (DI) Information

Brand Name: Soviflex
Version or Model: 1001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1001
Company Name: Birch Concepts LLC

Primary DI Number: B79510010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 042601599 *Terms of Use

Device Description: Post-parturition vaginal retractor intended to retract the vaginal walls following childbirth for improved visualization and access during surgical repair (e.g. suturing) of vaginal tears.

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:	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?
66432	Post-parturition vaginal retractor	A dedicated device intended to retract the vaginal walls following childbirth for improved visualization and access during surgical repair (e.g., suturing) of vaginal tears. It is a non-hinged, self-retaining retractor typically in the form of a polymer sheet/leaflet designed to be bent and inserted into the vagina whereby it self-expands to dilate the vaginal opening. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HDL	Retractor, Vaginal

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: c7a75eff-530d-49a7-af89-62673ae75d73
Public Version Date: March 19, 2024
Public Version Number: 2
DI Record Publish Date: September 06, 2022