FDA.reportPublic FDA data

HUMI

Primary DI
20888937013232
Brand
HUMI
Company
Coopersurgical, Inc.
Model
6001
Device description
HUMI® Harris-Kronner Uterine Manipulator-Injector O.D.: 5 mm • Length: 33 cm (13") • Recommended Balloon Inflation: Air 10 cc
Published
2016-09-14
Public version status
Update
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
KNAInstrument, Manual, Specialized Obstetric-Gynecologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNAInstrument, Manual, Specialized Obstetric-GynecologicObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K770727000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K770727000MANIPULATOR & INJECTOR, UTERINENational Catheter Co. Div. Mallinckrodt1977-04-26KNA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888937013232PackageGS112In Commercial Distribution
00888937013238PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088893701323220888937013232
00888937013238008889370132388889370132380888937013238

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
00888937028508LifeGlobal® MediaH5TF-010MH5TF-010M2026-05-11
00888937028515LifeGlobal® MediaH5TF-050MH5TF-050M2026-05-11
00888937028522LifeGlobal® MediaH5TF-100MH5TF-100M2026-05-11
00888937028539LifeGlobal® MediaLGGF-050MLGGF-050M2026-05-11
00888937028546LifeGlobal® MediaLGGF-100MLGGF-100M2026-05-11
00888937028614LifeGlobal® MediaGCOL-100MGCOL-100M2026-05-11
00888937028621LifeGlobal® MediaGCOL-500MGCOL-500M2026-05-11
00888937028638LifeGlobal® MediaLGOL-100MLGOL-100M2026-05-11
00888937028645LifeGlobal® MediaLGOL-500MLGOL-500M2026-05-11
00888937028652LifeGlobal® MediaAMLO-100MAMLO-100M2026-05-11
00888937028669LifeGlobal® MediaLGPO-100MLGPO-100M2026-05-11
00888937028676LifeGlobal® MediaLGPO-500MLGPO-500M2026-05-11
00888937028683LifeGlobal® MediaAMPO-100MAMPO-100M2026-05-11
00888937028690LifeGlobal® MediaLGUA-100MLGUA-100M2026-05-11
00888937028706LifeGlobal® MediaLGUA-500MLGUA-500M2026-05-11
00888937028713LifeGlobal® MediaAMLG-100MAMLG-100M2026-05-11
00888937028935LifeGlobal® MediaH5TH-050MH5TH-050M2026-05-11
00888937028942LifeGlobal® MediaH5TH-100MH5TH-100M2026-05-11
00888937029017LifeGlobal® MediaLGGH-050MLGGH-050M2026-05-11
00888937029024LifeGlobal® MediaLGGH-100MLGGH-100M2026-05-11

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Primary DI, Brand, Company table
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00841019123409KirwanKIRWAN SURGICAL PRODUCTS LLCKNA2025-07-19
04719894433400Cooper SurgicalBioteque Taiwan Ltd.KNA2025-03-11
04719894433424Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.KNA2025-03-10
00841019122822KirwanKIRWAN SURGICAL PRODUCTS LLCKNA2025-02-15
00841019122334KirwanKIRWAN SURGICAL PRODUCTS LLCKNA2024-09-14
00841019122341KirwanKIRWAN SURGICAL PRODUCTS LLCKNA2024-09-14
04719894432540Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.KNA2024-04-08
04719894432557Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.KNA2024-04-08
00841019121801KirwanKIRWAN SURGICAL PRODUCTS LLCKNA2023-11-03
GYNX102001GynexGYNEX CORPORATIONKNA2023-06-28
00841019121023KirwanKIRWAN SURGICAL PRODUCTS LLCKNA2022-06-03
00841019120996KirwanKIRWAN SURGICAL PRODUCTS LLCKNA2022-05-17
00841019121009KirwanKIRWAN SURGICAL PRODUCTS LLCKNA2022-05-17
00841019120989KirwanKIRWAN SURGICAL PRODUCTS LLCKNA2022-05-11
00841019118306KirwanKIRWAN SURGICAL PRODUCTS LLCKNA2020-01-28
00841019118313KirwanKIRWAN SURGICAL PRODUCTS LLCKNA2020-01-28
10653160331100CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKNA2019-11-04
00653160331103CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKNA2019-11-04
10653160328636CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKNA2019-08-23
10653160326045CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKNA2019-04-13
00653160326048CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKNA2019-04-13
00841019117729KirwanKIRWAN SURGICAL PRODUCTS LLCKNA2019-02-28
00841019117668KirwanKIRWAN SURGICAL PRODUCTS LLCKNA2019-01-04
00841019116548KirwanKIRWAN SURGICAL PRODUCTS LLCKNA2018-08-22
00841019116555KirwanKIRWAN SURGICAL PRODUCTS LLCKNA2018-08-22
00841019116586KirwanKIRWAN SURGICAL PRODUCTS LLCKNA2018-08-22