Pessary, Vaginal

Panpac’s pessaries are indicated for use as removable structures placed in the vagina to support the pelvic organs. Pessary use is contraindicated in cases of acute genital tract…

Registry build 21.09.26

Panpac’s pessaries are indicated for use as removable structures placed in the vagina to support the pelvic organs. Pessary use is contraindicated in cases of acute genital tract inflections, pelvic inflections, or non-compliant patients.

4manufacturers in China registered for this device type
628catalogue numbers in this listing
4510(k) clearances naming this product code

Who Else Makes It

All of them in Guangdong. 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HHW
Manufacturer City Province Registered as Device types
Modern Medical Equipment Manufacturing Ltd. Heng Li, Dongguan Guangdong Contract manufacturer 26
B&A Precision Silicone Rubber (Dongguan) Co., Ltd. Dongguan Guangdong Contract manufacturer 4
Guangzhou Fame Medical Co., Ltd. Guangzhou Guangdong Contract manufacturer 1
Modern Medical Equipment Manufacturing (Qing Yuan) Ltd Qing Yuan Guangdong Contract manufacturer 26

Record

Regulatory record for Pessary, Vaginal
Listed by Panpac Medical Corporation, Taiwan
FDA product code HHW
Device type Pessary, Vaginal
Device class Class 2
Regulation 21 CFR 884.3575
510(k) K161106
Record published 2016-08-18
Record revised 2022-11-07 (version 5)

Specifications

Specifications
MRI safety MR Unsafe
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, expiry date, manufacturing date
Packaging Box of 10
Distribution end date 2016-08-18
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Pessary, Vaginal
Catalogue number Size Status
Gd9-W In distribution
DSH1-W In distribution
CUd1 In distribution
GS7 In distribution
DSHs3 In distribution
Gd0-W In distribution
RK3-W In distribution
RKs6-W In distribution
M6-P In distribution
D1-P In distribution
M3-W In distribution
GS6 In distribution
Gd1 In distribution
RKs2-P In distribution
R1-P In distribution
CUd3 In distribution
Rs0-P In distribution
HDs8-W In distribution
IR4 In distribution
RK5-P In distribution
RK0-W In distribution
GS4-P In distribution
CUd2-W In distribution
CU2-P In distribution
Rs8-P In distribution
CP6 In distribution
DSHs3-W In distribution
HDs7-W In distribution
FS6000 In distribution
CPs6-W In distribution
HDs6-W In distribution
SH6-W In distribution
DSHs6-P In distribution
RKs4 In distribution
GS9-P In distribution
M4-P In distribution
GH4 In distribution
RK5 In distribution
DSHs2 In distribution
CUd8-W In distribution
RKs3-P In distribution
CPs2 In distribution
D4 In distribution
KC09 In distribution
HD9-P In distribution
OV7-P In distribution
ID5 In distribution
D7 In distribution
Ms7-W In distribution
Rs5-W In distribution
D2 In distribution
CPs6 In distribution
GS0 In distribution
FS9000 In distribution
CU4-P In distribution
CU4 In distribution
SH8 In distribution
CU2-W In distribution
CP3-P In distribution
CUd7-P In distribution
Ms5 In distribution
RK0-P In distribution
R7-P In distribution
Gd3 In distribution
SH3 In distribution
HDs0 In distribution
Gd9-P In distribution
RKs7-W In distribution
RK4-P In distribution
CU4-W In distribution
DSHs3-P In distribution
R8 In distribution
M6-W In distribution
HDs2 In distribution
GH5-P In distribution
HD6-P In distribution
OVs1-P In distribution
D3-P In distribution
M7-P In distribution
OV7-W In distribution
SH5-W In distribution
OV3-P In distribution
R2 In distribution
RKs5 In distribution
CPs3-W In distribution
R8-W In distribution
CU6-W In distribution
CUd8 In distribution
M2-P In distribution
OV9-W In distribution
Rs6 In distribution
FSP10 In distribution
DSHs0-P In distribution
FS5000 In distribution
Ms3-W In distribution
OV2-W In distribution
RKs6-P In distribution
GS1 In distribution
RKs3 In distribution
GS3 In distribution
CPs0 In distribution
Rs4-P In distribution
HD6-W In distribution
R6-W In distribution
OV1-W In distribution
HDs9 In distribution
Rs1-P In distribution
CUd9-W In distribution
SH8-W In distribution
HD0-W In distribution
CUd4-W In distribution
Gd4 In distribution
HD0-P In distribution
CU8 In distribution
RKs2 In distribution
OVs4-P In distribution
HD5-W In distribution
Rs5 In distribution
OVs5-P In distribution
CU7 In distribution
RKs4-P In distribution
RK5-W In distribution
OVs9-W In distribution
HD4 In distribution
KC04 In distribution
HDs3-W In distribution
GS5 In distribution
FS1000 In distribution
RK7-P In distribution
Rs8-W In distribution
Ms8-W In distribution
DSHs7-P In distribution
GH6 In distribution
DISP-R3 In distribution
DSHs6 In distribution
D3-W In distribution
CP0 In distribution
Ms7 In distribution
R5 In distribution
IR6 In distribution
CU5 In distribution
DSH6 In distribution
CPs5-W In distribution
CP4-P In distribution
Gd0 In distribution
RK7-W In distribution
FS3000 In distribution
OVs2-W In distribution
DSH7-P In distribution
RKs2-W In distribution
Rs1-W In distribution
HD1-W In distribution
DSHs0 In distribution
FSP12 In distribution
D5-P In distribution
HD7-W In distribution
IR1 In distribution
GH3 In distribution
M4 In distribution
RK6-P In distribution
GH2 In distribution
CUd5 In distribution
DSHs1-P In distribution
DSH4-W In distribution
OV1 In distribution
CU0-P In distribution
M5 In distribution
CUd7-W In distribution
OV9 In distribution
OV3 In distribution
HD1-P In distribution
OVs1 In distribution
OVs6-P In distribution
GS6-W In distribution
DSH5 In distribution
CUd10-W In distribution
CP0-P In distribution
CPs3 In distribution
R3-P In distribution
OVs3-P In distribution
CPs4-W In distribution
M2-W In distribution
KC12 In distribution
R9-W In distribution
Gd4-W In distribution
DSHs6-W In distribution
CPs1-P In distribution
GH4-P In distribution
OVs2-P In distribution
D0-W In distribution
SH7-W In distribution
OVs4 In distribution
Rs7 In distribution
Gd3-P In distribution
R1-W In distribution
M2 In distribution
CUd4 In distribution
CU9-P In distribution
KC08 In distribution
HDs0-W In distribution
FS8000 In distribution
DSH5-W In distribution
SH9-W In distribution
OVs5 In distribution
OV5-W In distribution
CP0-W In distribution
HD8-W In distribution
OV4-W In distribution
GH2-P In distribution
D6 In distribution
GH1-P In distribution
HDs4 In distribution
DSH2-P In distribution
OV6-W In distribution
HD3-P In distribution
DSHs4 In distribution
OV8-P In distribution
ID4 In distribution
Ms4-W In distribution
GS7-P In distribution
Rs8 In distribution
Gd6-W In distribution
IR9 In distribution
DSH6-P In distribution
D5-W In distribution
Rs3-W In distribution
GS9-W In distribution
CUd6-P In distribution
GSR1 In distribution
DSH0 In distribution
ID3 In distribution
RK4 In distribution
GS0-P In distribution
D6-P In distribution
M4-W In distribution
DISP-R7 In distribution
RK3-P In distribution
CUd7 In distribution
RKs5-W In distribution
D7-W In distribution
FS1100 In distribution
SH9 In distribution
FSP08 In distribution
HDs0-P In distribution
Ms4-P In distribution
GS3-P In distribution
DSH1 In distribution
Gd1-W In distribution
CP7 In distribution
Rs2 In distribution

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Milex Coopersurgical, Inc. 592
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Bioteque Bioteque Taiwan Ltd. 209
Integra® Miltex® Integra LifeSciences Production Corporation 189
HNM Women Care HNM Stainless, LLC. 187
Medline Medline Industries, Inc. 162
Marina Medical Marina Medical Instruments, Inc. 144
EvaCare Personal Medical Corp. 128
Hayden Medical Hayden Medical Inc 81
Premier Premier Dental Products Co. 58
LTL Medical Bioteque Taiwan Ltd. 56
Sklar® Sklar Corporation 37

Showing 12 of 180. All products under Pessary, Vaginal

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K173351 2018-10-31
K153422 2016-07-14
K132670 2014-06-04
K092981 2010-07-22

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer