FDA.reportPublic FDA data

Kronner Manipujector

Primary DI
00888937015805
Brand
Kronner Manipujector
Company
Coopersurgical, Inc.
Model
6003
Device description
Uterine manipulator
Published
2019-01-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HESInsufflator, Carbon-Dioxide, Uterotubal (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HESInsufflator, Carbon-Dioxide, Uterotubal (And Accessories)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K904473000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K904473000KRONNER MANIPUJECTORUnimar, Inc.1990-12-14HES

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888937015809PackageGS112In Commercial Distribution
00888937015805PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088893701580920888937015809
00888937015805008889370158058889370158050888937015805

GMDN Terms#

Term, Definition table
TermDefinition
Uterine manipulator, single-useA sterile, hand-held manual surgical instrument designed to atraumatically mechanically manipulate the position of the uterus during a gynaecological intervention (e.g., laparoscopy) to enable uterine control and improved visibility of the pelvic anatomy, as well as for chromotubation. The device typically consists of a long shaft with an inflatable balloon at the distal end which is transcervically placed inside the uterus and inflated, via a connected syringe (sometimes included), with sterile saline or air; once inflated, the operator can manipulate the uterus. Deflation is a reverse of the inflation process. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length33Centimeter
Outer Diameter5Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
801895244
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
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
05055270966148RocketROCKET MEDICAL PLCHES2023-10-31
05055270974440RocketROCKET MEDICAL PLCHES2023-10-31
05055270966155RocketROCKET MEDICAL PLCHES2023-10-31
05055270974457RocketROCKET MEDICAL PLCHES2023-10-31
05055270981370RocketROCKET MEDICAL PLCHES2023-10-24
05055270981387RocketROCKET MEDICAL PLCHES2023-10-24
00887517021472PRECICE® Plating SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.HES2020-01-06
20888937014765Kronner ManipujectorCoopersurgical, Inc.HES2019-01-31
00827002303683CookCOOK INCORPORATEDHES2016-11-04
10653405045465CORE DYNAMICSConmed CorporationHES2016-09-24
10653405045472CORE DYNAMICSConmed CorporationHES2016-09-24
00827002248137uVueCOOK INCORPORATEDHES2016-09-24
10885403045080V. MuellerSTERIS CORPORATIONHES2016-09-24
10885403045097V. MuellerSTERIS CORPORATIONHES2016-09-24
10885403045110V. MuellerSTERIS CORPORATIONHES2016-09-24
10885403045127V. MuellerSTERIS CORPORATIONHES2016-09-24
10885403050084V. MuellerSTERIS CORPORATIONHES2016-09-24
20653405045479CORE DYNAMICSConmed CorporationHES2016-09-24
10885403045134V. MuellerCAREFUSION 2200, INCHES2016-09-24
00827002165755SholkoffCOOK INCORPORATEDHES2016-09-24
10827002171470CookCOOK INCORPORATEDHES2016-09-24
10827002174716CookCOOK INCORPORATEDHES2016-09-24
10827002174723CookCOOK INCORPORATEDHES2016-09-24
00827002175907CookCOOK INCORPORATEDHES2016-09-24
10827002178707CookCOOK INCORPORATEDHES2016-09-24
10827002248134uVueCOOK INCORPORATEDHES2016-09-24
00827002303973CookCOOK INCORPORATEDHES2016-09-24
30653405074728CORE DYNAMICSConmed CorporationHES2016-09-24
70885403159956V. MuellerSTERIS CORPORATIONHES2016-09-24
00827002104327MenciniCOOK INCORPORATEDHES2016-09-24