FDA.reportPublic FDA data

NA

Primary DI
04715309124871
Brand
NA
Company
PANPAC MEDICAL CORPORATION
Model
CuRc11
Device description
"""Measure uterine depth. Dilate the cervix if necessary. Introduce INTRACURETTE through the cervical canal into the uterus up to the fundus. Connect the curette to the suction system. Operate by rotating the curette 360∘ to aspirate throughout the uterus cavity accurately.Repeat the operation two or three times. Withdraw INTRACURETTE from the uterus while continuing the rotating movement. """
Published
2017-05-10
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HGHCannula, Suction, Uterine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGHCannula, Suction, UterineObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161106000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161106000PANPAC DISPOSABLE VACUUM CURETTESPanpac Medical Corporation2017-01-13HGH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04715309125397PackageGS110In Commercial Distribution
04715309124871PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04715309125397047153091253974715309125397
04715309124871047153091248714715309124871

GMDN Terms#

Term, Definition table
TermDefinition
Intrauterine curette, suctionA sterile, tubular, semi-rigid, hand-held device used to scrape the lining of the uterus for the removal of tissue during a gynaecological procedure, typically for the removal of an early or non-viable embryo/foetus. The device typically has a rounded blunt nose and an opening(s) with a blunt scraping edge(s) at the distal end. It is connected at the proximal end to tubing and a suction source, typically an abortion suction system, which provides regulated suction. Also known as a pregnancy termination catheter, it is typically made of plastic and is available in various shapes and sizes. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+866286472242service@panpac.com.tw

Regulatory Flags#

DUNS number
657528899
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04713025224004NABA05F-S2018-07-09
04715309122891The O.R. Company LLCUMI 4.5C-D2016-08-15
04715309122914The O.R. Company LLCUMI 4.5KC-D2016-08-15
04715309124987NAM00142016-08-15
04715309124994NARD0032016-08-15
04715309125014NAM00162016-08-15
04715309125021NAM00152016-08-15
04715309125038NAWC-400MM2016-08-15
04715309125045NABA05F2016-08-15
04715309125052NABA07F2016-08-15
04715309125069NAUIC5F2016-08-15
04715309125113NABA051F2016-08-15
04715309125120NABA071F2016-08-15
04715309125137NAUI 4.02016-08-15
04715309125144NAUI 2.02016-08-15
04715309125151NAUIC5FA2016-08-15
04715309125182NAUIC5FAX2016-08-15
04715309125199NAUMI 4.52016-08-15
04715309125205NAUMI 4.5K2016-08-15
04715309125229NAUMI 4.5C2016-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06946332802131GynoVisionChongqing Jinshan Science & Technology (Group) Co., LtdHGH2020-09-01
06946332802193GynoVisionChongqing Jinshan Science & Technology (Group) Co., LtdHGH2020-09-01
06946332802254GynoVisionChongqing Jinshan Science & Technology (Group) Co., LtdHGH2020-09-01
06946332802117GynoVisionChongqing Jinshan Science & Technology (Group) Co., LtdHGH2020-09-01
06946332802148GynoVisionChongqing Jinshan Science & Technology (Group) Co., LtdHGH2020-09-01
06946332802209GynoVisionChongqing Jinshan Science & Technology (Group) Co., LtdHGH2020-09-01
06946332802261GynoVisionChongqing Jinshan Science & Technology (Group) Co., LtdHGH2020-09-01
04715309124758NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309124765NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309124772NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309124789NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309124802NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309124819NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309124826NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309124833NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309124840NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309124857NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309124864NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309124888NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309125274NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309125281NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309125298NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309125304NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309124796NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309125328NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309125335NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309125342NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309125359NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309125366NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309125373NAPANPAC MEDICAL CORPORATIONHGH2017-05-10