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Soviflex

FDA UDI

Class I (US FDA UDI)

by Birch Concepts LLC

Identity

Trade Name
Soviflex FDA UDI
Generic Name
Post-parturition vaginal retractor FDA UDI
Device Name
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. FDA UDI
Model / Reference
1001 FDA UDI
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. FDA UDI

Identifiers

Catalog Number
1001 FDA UDI
Primary DI / UDI-DI
B79510010 FDA UDI
FDA Product Code
HDL FDA UDI
GMDN Term
Post-parturition vaginal retractor FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
884.4520 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Post-parturition vaginal retractor

Soviflex by Birch Concepts LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Post-parturition vaginal retractor.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Birch Concepts LLC

Sources (1)

  • FDA UDI c7a75eff-530d-49a7-af89-62673ae75d73 34 fields · synced May 29, 2026