FDA.reportPublic FDA data

NA

Primary DI
04715309125366
Brand
NA
Company
PANPAC MEDICAL CORPORATION
Model
CuRc08
Device description
"Measure uterine depth. Dilate the cervix if necessary. Introduce INTRACURETTE through the cervical canal into the uterus up to the fundus. Connect th
Published
2017-05-10
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

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
04715309125366PackageGS110In Commercial Distribution
04715309124840PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04715309125366047153091253664715309125366
04715309124840047153091248404715309124840

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
657528899
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

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
04715309124871NAPANPAC 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
04715309125373NAPANPAC MEDICAL CORPORATIONHGH2017-05-10