FDA.reportPublic FDA data

NA

Primary DI
04713025223854
Brand
NA
Company
PANPAC MEDICAL CORPORATION
Model
KC09
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
04713025223939PackageGS110In Commercial Distribution
04713025223854PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04713025223939047130252239394713025223939
04713025223854047130252238544713025223854

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
00348783015829PremierBioteque Taiwan Ltd.HHW2026-11-03
00348783015836PremierBioteque Taiwan Ltd.HHW2026-11-03
00348783015843PremierBioteque Taiwan Ltd.HHW2026-11-03
00348783015850PremierBioteque Taiwan Ltd.HHW2026-11-03
00348783015867PremierBioteque Taiwan Ltd.HHW2026-11-03
00348783015874PremierBioteque Taiwan Ltd.HHW2026-11-03
00348783015881PremierBioteque Taiwan Ltd.HHW2026-11-03
00348783015898PremierBioteque Taiwan Ltd.HHW2026-11-03
00348783015904PremierBioteque Taiwan Ltd.HHW2026-11-03
00348783015911PremierBioteque Taiwan Ltd.HHW2026-11-03
00348783015928PremierBioteque Taiwan Ltd.HHW2026-11-03
00348783015935PremierBioteque Taiwan Ltd.HHW2026-11-03
00348783015942PremierBioteque Taiwan Ltd.HHW2026-11-03
00348783015959PremierBioteque Taiwan Ltd.HHW2026-11-03
00348783015966PremierBioteque Taiwan Ltd.HHW2026-11-03
00348783015973PremierBioteque Taiwan Ltd.HHW2026-11-03
00348783015980PremierBioteque Taiwan Ltd.HHW2026-11-03
00348783015997PremierBioteque Taiwan Ltd.HHW2026-11-03
00348783016000PremierBioteque Taiwan Ltd.HHW2026-11-03
00348783016017PremierBioteque Taiwan Ltd.HHW2026-11-03
00348783016024PremierBioteque Taiwan Ltd.HHW2026-11-03
00348783016031PremierBioteque Taiwan Ltd.HHW2026-11-03
00348783016123PremierBioteque Taiwan Ltd.HHW2026-11-03
00348783016130PremierBioteque Taiwan Ltd.HHW2026-11-03
00348783016147PremierBioteque Taiwan Ltd.HHW2026-11-03
00348783016154PremierBioteque Taiwan Ltd.HHW2026-11-03
00348783016161PremierBioteque Taiwan Ltd.HHW2026-11-03
00348783016178PremierBioteque Taiwan Ltd.HHW2026-11-03
00348783016185PremierBioteque Taiwan Ltd.HHW2026-11-03
00348783016192PremierBioteque Taiwan Ltd.HHW2026-11-03