FDA.reportPublic FDA data

CODMAN®

Primary DI
10381780532873
Brand
CODMAN®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
901001IRRO
Catalog number
901001IRRO
Device description
Codman® Electrosurgical Irrigator
Published
2020-04-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, cutting & coagulation & accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182801000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182801000Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator Interconnecting CableIntegra LifeSciences Corporation2018-11-27GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780532873PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178053287310381780532873

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation pumpAn electrically-powered device, which may include noninvasive accessories, intended to pump a sterile fluid (e.g., saline water) to irrigate body cavities/wounds during surgery (e.g., general surgery, endoscopic). It is typically intended to be used to wash away tissues/fluids/debris with a sterile fluid to facilitate observation; it is not intended to administer parenteral fluids or drugs and is not capable of suction. The device may incorporate a display and may include collection containers or tubing; it does not include patient contact devices (e.g., handpiece/tip, catheter).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure50 KiloPascal105 KiloPascal
Handling Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature-40 Degrees Fahrenheit122 Degrees Fahrenheit
Handling Environment Temperature-20 Degrees Celsius50 Degrees Celsius
Special Storage Condition, Specify00Waste from Electrical and Electronic Equipment
Storage Environment Atmospheric Pressure50 KiloPascal105 KiloPascal
Storage Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius50 Degrees Celsius
Storage Environment Temperature-40 Degrees Fahrenheit122 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
081277700
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780191070Integra® Jarit®400293400-2932018-04-02
10381780193180Integra® Jarit®P408P4082018-04-02
10381780197997Integra® Jarit®380232380-2322017-09-29
10381780198000Integra® Jarit®380233380-2332018-03-22
10381780198543Integra® Jarit®385295385-2952018-03-22
10381780220121Integra® Jarit®P666P6662018-01-31
10381780390381Integra® Jarit®380230380-2302018-02-16
10381780390398Integra® Jarit®380231380-2312018-02-16
10381780456469Integra® Jarit®405225405-2252018-01-31
10381780457190Integra® Jarit®P667P6672018-01-31
10381780458159Integra® Jarit®385315385-3152018-03-01
10381780458166Integra® Jarit®385316385-3162018-03-01
10381780487708Integra® Miltex®MH21-300MH21-3002018-08-22
10381780503910Integra® Miltex®PM-666PM-6662020-10-01
10381780520665CereLink™82684582-68452020-04-01
10381780087984Integra®375001237500122018-10-26
10381780081371Integra®372201137220112018-10-24
10381780081388Integra®372201237220122018-10-24
10381780081906Integra®372206937220692018-10-24
10381780081913Integra®372207037220702018-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776429140MillenniumAvalign Technologies, Inc.GEI2026-09-04
00840113233281BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233304BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233328BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233342BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233366BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233380BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233403BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233427BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233441BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233465BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233489BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233502BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233526BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237326BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237340BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237593BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237623BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237661BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237692BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00190776428006MillenniumAvalign Technologies, Inc.GEI2026-08-27
00190776428037MillenniumAvalign Technologies, Inc.GEI2026-08-27
B4193533010Maxtown MedicalModern Surgical Instruments LLCGEI2026-08-27
ESUMARS980010SutterSutter Medizintechnik GmbHGEI2026-08-27
00190776427436MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427542MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427573MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427672MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427689MillenniumAvalign Technologies, Inc.GEI2026-08-26
B108890POAMUS00BTL-890UBTL INDUSTRIES LIMITEDGEI2026-08-26