FDA.reportPublic FDA data

Schroeder Double Tooth Side Curve

Primary DI
M803031013
Brand
Schroeder Double Tooth Side Curve
Company
MEDGYN PRODUCTS, INC.
Model
"Schroeder Double Tooth Side Curve 10"" (254mm) "
Catalog number
031013
Device description
"Schroeder Double Tooth Side Curve 10"" (254mm) "
Published
2025-11-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
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
M803031013PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Uterine tenaculumA hand-held manual surgical instrument with hooks at the distal end used for grasping and/or manipulating uterine tissue during a surgical intervention or examination of the uterus and associated structures (e.g., cervix). It typically has a scissors-like, self-retaining design with ring handles and is made of high-grade stainless steel. It is available in various sizes. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
103913430
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M8030030134Baby Tischler Biopsy Punch Titanium"Baby Tischler Biopsy Punch Titanium 10"" (254mm) 0301342025-11-16
M8030030139Tischler Biopsy Punch Titanium"Tischler Biopsy Punch Titanium 8 1/2"" (216mm) - 0301392025-11-16
M803029801Tischler Biopsy Punch "Tischler Biopsy Punch 10"" (254mm) Up"0298012025-11-16
M803029802Tischler Biopsy Punch "Tischler Biopsy Punch 10"" (254mm) Down"0298022025-11-16
M803029803Tischler Biopsy Punch"Tischler Biopsy Punch 10"" (254mm) Left"0298032025-11-16
M803029804Tischler Biopsy Punch "Tischler Biopsy Punch 10"" (254mm) Right"0298042025-11-16
M803029811Baby Tischler Biopsy Punch "Baby Tischler Biopsy Punch 10"" (254mm) Up "0298112025-11-16
M803029812Baby Tischler Biopsy Punch "Baby Tischler Biopsy Punch 10"" (254mm) Down"0298122025-11-16
M803029813Baby Tischler Biopsy Punch"Baby Tischler Biopsy Punch 10"" (254mm) Left"0298132025-11-16
M803029814Baby Tischler Biopsy Punch "Baby Tischler Biopsy Punch 10"" (254mm) Right"0298142025-11-16
M803030101Tischler Biopsy Punch"Tischler Biopsy Punch 81/2"" (216mm)"0301012025-11-16
M80303010110"Tischler Biopsy Punch 10"" (254mm)""Tischler Biopsy Punch 10"" (254mm)"030101102025-11-16
M803030102Baby Tischler Biopsy Punch"Baby Tischler Biopsy Punch 81/2"" (216mm)"0301022025-11-16
M80303010210Baby Tischler Biopsy Punch"Baby Tischler Biopsy Punch 10""(254mm)"030102102025-11-16
M803030103Kevorkian Biopsy Punch"Kevorkian Biopsy Punch 81/2"" (216mm)"0301032025-11-16
M80303010310Kevorkian Biopsy Punch"Kevorkian Biopsy Punch 10"" (254mm)"030103102025-11-16
M803030104Rotating Tischler Biopsy PunchRotating Tischler Biopsy Punch0301042025-11-16
M803030105Rotating Baby Tischler Biopsy PunchRotating Baby Tischler Biopsy Punch0301052025-11-16
M803030106Rotating Kevorkian Biopsy PunchRotating Kevorkian Biopsy Punch0301062025-11-16
M803030107Rotating Burke Biopsy PunchRotating Burke Biopsy Punch0301072025-11-16

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