FDA.reportPublic FDA data

Labor Guard Perianal Stabilizer

Primary DI
00855459008097
Brand
Labor Guard Perianal Stabilizer
Company
Stetrix, Inc.
Model
LG-01
Published
2024-11-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PNUPressure Wedge, Perianal, For Reduction Of Cesarean Delivery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PNUPressure Wedge, Perianal, For Reduction Of Cesarean DeliveryObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN160005000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN160005000Hem-Avert Perianal StabilizerStetrix, Inc.2016-12-19PNU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10855459008094PackageGS15In Commercial Distribution
00855459008097PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085545900809410855459008094
00855459008097008554590080978554590080970855459008097

GMDN Terms#

Term, Definition table
TermDefinition
Obstetrical/gynaecological surgical procedure kit, non-medicated, single-useA collection of various sterile surgical instruments, dressings/drapes, and materials intended to be used during obstetrical/gynaecological surgery. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of obstetrical/gynaecological surgical procedure, but are often supplied together to perform a specific type of obstetrical/gynaecological procedure; it does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
827509667
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
90855459008106LyfteeLYFY-012025-01-17
00855459008134Jannus Pannus RetractorPPR-182025-01-17
00855459008042Pannus Retention SystemTRS-062025-01-10
00855459008059Pannus Retention SystemTRS-082025-01-10
00855459008080Panni Retractor SystemPPR-132025-01-10
00855459008004Pannus Retention SystemTRS-042025-01-10
10855459008049Pannus Retention SystemTRS-062025-01-10
10855459008056Pannus Retention SystemTRS-082025-01-10
10855459008087Panni Retractor SystemPPR-132025-01-10