FDA.reportPublic FDA data

NA

Primary DI
04713025223847
Brand
NA
Company
PANPAC MEDICAL CORPORATION
Model
KC08
Device description
"""Panpac karman curette(or cannula) is a flexible plastic currette incorporates with vacuum aspiration syringes to provide a safe, efficient and fast vacuum aspiration method to evacuate the contents of the uterus. """
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
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
04713025223922PackageGS110In Commercial Distribution
04713025223847PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04713025223922047130252239224713025223922
04713025223847047130252238474713025223847

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
No 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
00850073946008EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946015EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946022EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946039EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946046EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946053EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946060EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946077EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946084EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946091EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946107EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946114EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946121EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946138EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946145EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946152EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946169EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946176EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946183EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946190EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946206EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946213EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946220EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946237EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946244EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946251EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946268EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946275EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946282EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14
00850073946299EvaCarePERSONAL MEDICAL CORP.HHW2026-07-14