FDA.reportPublic FDA data

Kronner Manipujector

Primary DI
20888937014765
Brand
Kronner Manipujector
Company
Coopersurgical, Inc.
Model
6003
Device description
Uterine manipulator, box of 12
Published
2019-01-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
20888937014765PackageGS112In Commercial Distribution
00888937015805PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088893701476520888937014765
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
801895244
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
00888937015805Kronner 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