FDA.reportPublic FDA data

Cooper Surgical

Primary DI
04719894433400
Brand
Cooper Surgical
Company
Bioteque Taiwan Ltd.
Model
53404
Published
2025-03-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
04719894433400PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719894433400047198944334004719894433400

GMDN Terms#

Term, Definition table
TermDefinition
Bartholin's gland catheterA short (e.g., 5 cm) plastic tube designed to form a tract from either of the two small reddish glands (Bartholin's glands), one on each side of the vaginal orifice, to the space where the urethra and the vagina open (vaginal vestibulum). It may include a balloon at the tip to ensure retention within the gland. The device is typically used for drainage in the treatment of Bartholin's gland cysts and abscesses. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
657769858
Device count
1
Kit
true
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
00860011716853Monarch Medical ProductsMM1150A2026-07-24
00860011927617Monarch Medical ProductsMM012502026-07-24
00860011927662Monarch Medical ProductsMM00152026-07-24
00860011927686Monarch Medical ProductsMM010252026-07-24
04719894435893LTL MedicalCUd12026-07-24
04719894435909LTL MedicalCUd22026-07-24
04719894435916LTL MedicalCUd32026-07-24
04719894435923LTL MedicalCUd42026-07-24
04719894435930LTL MedicalCUd52026-07-24
04719894435947LTL MedicalCUd62026-07-24
04719894435954LTL MedicalCUd72026-07-24
04719894435961LTL MedicalD12026-07-24
04719894435978LTL MedicalD22026-07-24
04719894435985LTL MedicalD32026-07-24
04719894435992LTL MedicalD42026-07-24
04719894436005LTL MedicalD52026-07-24
04719894436012LTL MedicalD62026-07-24
04719894436029LTL MedicalDSHs12026-07-24
04719894436036LTL MedicalDSHs22026-07-24
04719894436043LTL MedicalDSHs32026-07-24

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
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
00841019116593KirwanKIRWAN SURGICAL PRODUCTS LLCKNA2018-08-22