FDA.reportPublic FDA data

Rectal Probe

Primary DI
00888937016543
Brand
Rectal Probe
Company
Coopersurgical, Inc.
Model
900-595
Device description
Rectal probe
Published
2022-12-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00888937016543PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888937016543008889370165438889370165430888937016543

GMDN Terms#

Term, Definition table
TermDefinition
Rectal probeA hand-held manual surgical instrument designed for exploring the tissues and structures of the rectum during a gastroenterological/urological surgical procedure. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
801895244
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060488046858EZ-Strip131µm7-72-1131/202025-04-11
05060488046865EZ-Strip135µm7-72-1135/202025-04-11
05060488046872EZ-Strip145µm7-72-1145/202025-04-11
05060488046889EZ-Strip145µm Long7-72-1145L/202025-04-11
05060488046896EZ-Strip155µm7-72-1170/202025-04-11
05060488046902EZ-Strip170µm7-72-1170/202025-04-11
05060488046919EZ-Strip200µm7-72-1290/202025-04-11
05060488046926EZ-Strip290µm7-72-1290/202025-04-11
05060488046933EZ-Strip290µm7-72-1600/202025-04-11
05060488046940EZ-Tip75µm7-72-2075/12025-04-11
05060488046957EZ-Tip125µm7-72-2125/12025-04-11
05060488046964EZ-Tip135µm7-72-2135/12025-04-11
05060488046971EZ-Tip145µm7-72-2145/12025-04-11
05060488046988EZ-Tip155µm7-72-2155/12025-04-11
05060488046995EZ-Tip170µm7-72-2170/12025-04-11
05060488047008EZ-Tip200µm7-72-2200/12025-04-11
05060488047015EZ-Tip250µm7-72-2250/12025-04-11
05060488047022EZ-Tip290µm7-72/2290/12025-04-11
05060488047039EZ-Tip600µm7-72-2600/12025-04-11
05060488047046EZ-Tip75µm7-72-2075/52025-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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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