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
00888937033687ONETRACC1001502026-07-10
00888937033694ONETRACC1001652026-07-10
00888937033700ONETRACC1001702026-07-10
00888937033717ONETRACC1001802026-07-10
00888937033724ONETRACC1001902026-07-10
00888937033731ONETRAC LXC1002102026-07-10
00888937033748ONETRAC LXC1002202026-07-10
00888937033755ONETRAC LXC1002302026-07-10
00888937033762ONETRAC LXC1002402026-07-10
00888937033779ONETRAC LXC1002502026-07-10
00888937033786ONETRAC™ LXSC1002602026-07-10
00888937033793ONETRAC™ LXSC1002702026-07-10
00888937033809ONETRAC™ LXSC1002802026-07-10
00888937033816ONETRAC™ LXSC1002902026-07-10
00888937033823ONETRAC™ LXSC1102002026-07-10
00888937033830ONETRAC™ LXSC1102102026-07-10
00888937033847ONETRAC™ LXSC1102202026-07-10
00888937033854ONETRAC™ LXSC1103102026-07-10
00888937033861ONETRAC™ LXSC1103202026-07-10
00888937033663ONETRAC™C1001102026-07-09

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