FDA.reportPublic FDA data

NA

Primary DI
04713025223885
Brand
NA
Company
PANPAC MEDICAL CORPORATION
Model
KC04
Device description
"Panpac karman curette(or cannula) is a flexible plastic currette incorporates with vacuum aspiration syringes to provide a safe, efficient and fast v
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
HHWPessary, Vaginal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HHWPessary, VaginalObstetrics/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
04713025223885PackageGS110In Commercial Distribution
04713025223809PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04713025223885047130252238854713025223885
04713025223809047130252238094713025223809

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
false
No natural rubber latex
true
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

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