FDA.reportPublic FDA data

HUI

Primary DI
00888937013191
Brand
HUI
Company
Coopersurgical, Inc.
Model
6002
Device description
"HUI® Harris Uterine Injector O.D.: 4.5 mm • Length: 22.9 cm (9"") • Recommended Balloon Inflation: Air 5cc"
Published
2016-09-14
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
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
20888937013195PackageGS112In Commercial Distribution
00888937013191PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088893701319520888937013195
00888937013191008889370131918889370131910888937013191

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.

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
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
Primary DIBrandCompanyProduct codePublished
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00841019123393KirwanKIRWAN SURGICAL PRODUCTS LLCKNA2025-07-19
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
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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