FDA.reportPublic FDA data

NA

Primary DI
04715309121986
Brand
NA
Company
PANPAC MEDICAL CORPORATION
Model
WC-400MM
Device description
The Word/Bartholin Catheter is used for the treatment of abscesses and cysts of the Bartholin gland.
Published
2016-08-15
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
KNAInstrument, Manual, Specialized Obstetric-Gynecologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNAInstrument, Manual, Specialized Obstetric-GynecologicObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130087000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130087000PANPAC WORD/BARTHOLIN CATHETERPanpac Medical Corporation2014-01-10KNA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04715309121986PackageGS11In Commercial Distribution
04715309125038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04715309121986047153091219864715309121986
04715309125038047153091250384715309125038

GMDN Terms#

Term, Definition table
TermDefinition
Cervical anaesthesia kitA collection of sterile devices designed to deliver an analgesic or anaesthetic agent to function as an intracervical nerve-block and/or a paracervical regional nerve-block (sometimes including uterosacral and pudendal regions). It is typically used for gyneacological diagnostic tests such as dilation and curettage, small excisional procedures such as endometrial biopsy, or for pain management during labour and/or delivery. It typically consists of a procedural needle, syringe, catheter, and a filter. 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
true
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841019123539KirwanKIRWAN SURGICAL PRODUCTS LLCKNA2025-09-03
00841019123522KirwanKIRWAN SURGICAL PRODUCTS LLCKNA2025-08-29
00841019123386KirwanKIRWAN SURGICAL PRODUCTS LLCKNA2025-07-19
00841019123393KirwanKIRWAN SURGICAL PRODUCTS LLCKNA2025-07-19
00841019123409KirwanKIRWAN SURGICAL PRODUCTS LLCKNA2025-07-19
04719894433400Cooper SurgicalBioteque Taiwan Ltd.KNA2025-03-11
04719894433424Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.KNA2025-03-10
00841019122822KirwanKIRWAN SURGICAL PRODUCTS LLCKNA2025-02-15
00841019122334KirwanKIRWAN SURGICAL PRODUCTS LLCKNA2024-09-14
00841019122341KirwanKIRWAN SURGICAL PRODUCTS LLCKNA2024-09-14
04719894432540Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.KNA2024-04-08
04719894432557Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.KNA2024-04-08
00841019121801KirwanKIRWAN SURGICAL PRODUCTS LLCKNA2023-11-03
GYNX102001GynexGYNEX CORPORATIONKNA2023-06-28
00841019121023KirwanKIRWAN SURGICAL PRODUCTS LLCKNA2022-06-03
00841019120996KirwanKIRWAN SURGICAL PRODUCTS LLCKNA2022-05-17
00841019121009KirwanKIRWAN SURGICAL PRODUCTS LLCKNA2022-05-17
00841019120989KirwanKIRWAN SURGICAL PRODUCTS LLCKNA2022-05-11
00841019118306KirwanKIRWAN SURGICAL PRODUCTS LLCKNA2020-01-28
00841019118313KirwanKIRWAN SURGICAL PRODUCTS LLCKNA2020-01-28
10653160331100CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKNA2019-11-04
00653160331103CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKNA2019-11-04
10653160328636CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKNA2019-08-23
10653160326045CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKNA2019-04-13
00653160326048CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKNA2019-04-13
00841019117729KirwanKIRWAN SURGICAL PRODUCTS LLCKNA2019-02-28
00841019117668KirwanKIRWAN SURGICAL PRODUCTS LLCKNA2019-01-04
00841019116548KirwanKIRWAN SURGICAL PRODUCTS LLCKNA2018-08-22
00841019116555KirwanKIRWAN SURGICAL PRODUCTS LLCKNA2018-08-22
00841019116586KirwanKIRWAN SURGICAL PRODUCTS LLCKNA2018-08-22