FDA.reportPublic FDA data

Releve

Primary DI
00850000610071
Brand
Releve
Company
SURGIN SURGICAL INSTRUMENTATION, INC.
Model
GY1500
Catalog number
GY1500
Device description
Intravaginal Support Device
Published
2023-07-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
KOHInstrument, Manual, General Obstetric-Gynecologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KOHInstrument, Manual, General Obstetric-GynecologicObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850000610071PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850000610071008500006100718500006100710850000610071

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal rectocele reduction instrumentA non-sterile, hand-held, retractor-like device intended to be used to manually reduce a rectocele (herniation of lower bowel/rectum through a vaginal wall tear) during defecation to facilitate bowel emptying. It is intended to be used by direct application into the vagina by the patient during routine self-treatment to replace digital reduction and as an alternative to the more permanent pessary or surgical repair. It is typically made of plastic material and can be reused after appropriate cleaning.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
076656164
Device count
1
Premarket exempt
true
Kit
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850000610088ReleveGY1530GY15302023-07-27
00850000610156ReleveGY1500/BX5GY1500/BX52023-07-27
00850000610002DoseRiteDRJ05AT-6DRJ05AT-62023-07-10
00850000610026DoseRiteDRJ05AT-6/BX10DRJ05AT-6/BX102023-07-10
00850000610033DoseRiteDRJ05AT-6MDRJ05AT-6M2023-07-10
00850000610064DoseRiteDR0084NL-12DR0084NL-122023-07-10
00850000610118DoseRiteDR-AIN01-USDR-AIN01-US2023-07-10
00868742000128Salgado DriverCR2000CR20002023-06-12
00868742000135Salgado DriverCR2005CR20052023-06-12
00868742000104Hemorrhage Occluder Pin with ApplicatorCR1007CR10072015-10-20
00868742000111Hemorrhage Occluder Pin with ApplicatorCR1014CR10142015-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M8030030134Baby Tischler Biopsy Punch TitaniumMEDGYN PRODUCTS, INC.KOH2025-11-16
M8030030139Tischler Biopsy Punch TitaniumMEDGYN PRODUCTS, INC.KOH2025-11-16
M803029801Tischler Biopsy Punch MEDGYN PRODUCTS, INC.KOH2025-11-16
M803029802Tischler Biopsy Punch MEDGYN PRODUCTS, INC.KOH2025-11-16
M803029803Tischler Biopsy PunchMEDGYN PRODUCTS, INC.KOH2025-11-16
M803029804Tischler Biopsy Punch MEDGYN PRODUCTS, INC.KOH2025-11-16
M803029811Baby Tischler Biopsy Punch MEDGYN PRODUCTS, INC.KOH2025-11-16
M803029812Baby Tischler Biopsy Punch MEDGYN PRODUCTS, INC.KOH2025-11-16
M803029813Baby Tischler Biopsy PunchMEDGYN PRODUCTS, INC.KOH2025-11-16
M803029814Baby Tischler Biopsy Punch MEDGYN PRODUCTS, INC.KOH2025-11-16
M803030101Tischler Biopsy PunchMEDGYN PRODUCTS, INC.KOH2025-11-16
M80303010110"Tischler Biopsy Punch 10"" (254mm)"MEDGYN PRODUCTS, INC.KOH2025-11-16
M803030102Baby Tischler Biopsy PunchMEDGYN PRODUCTS, INC.KOH2025-11-16
M80303010210Baby Tischler Biopsy PunchMEDGYN PRODUCTS, INC.KOH2025-11-16
M803030103Kevorkian Biopsy PunchMEDGYN PRODUCTS, INC.KOH2025-11-16
M80303010310Kevorkian Biopsy PunchMEDGYN PRODUCTS, INC.KOH2025-11-16
M803030104Rotating Tischler Biopsy PunchMEDGYN PRODUCTS, INC.KOH2025-11-16
M803030105Rotating Baby Tischler Biopsy PunchMEDGYN PRODUCTS, INC.KOH2025-11-16
M803030106Rotating Kevorkian Biopsy PunchMEDGYN PRODUCTS, INC.KOH2025-11-16
M803030107Rotating Burke Biopsy PunchMEDGYN PRODUCTS, INC.KOH2025-11-16
M803030108Rotating Biopsy Punch Handle OnlyMEDGYN PRODUCTS, INC.KOH2025-11-16
M803030109Burke Biopsy Punch MEDGYN PRODUCTS, INC.KOH2025-11-16
M803030110Eppendorfer Biopsy ForcepsMEDGYN PRODUCTS, INC.KOH2025-11-16
M803030113Tischler Biopsy PunchMEDGYN PRODUCTS, INC.KOH2025-11-16
M803030114Tischler Biopsy Punch MEDGYN PRODUCTS, INC.KOH2025-11-16
M803030115Tischler-Kevorkian Biopsy PunchMEDGYN PRODUCTS, INC.KOH2025-11-16
M803030116Tischler-Kevorkian Biopsy PunchMEDGYN PRODUCTS, INC.KOH2025-11-16
M803030117"Wittner Biopsy Punch 8.5"" (216mm)"MEDGYN PRODUCTS, INC.KOH2025-11-16
M803030118Tischler Biopsy Punch Titanium MEDGYN PRODUCTS, INC.KOH2025-11-16
M803030119Baby Tischler Biopsy Punch TitaniumMEDGYN PRODUCTS, INC.KOH2025-11-16