FDA.reportPublic FDA data

Sklar®

Primary DI
10649111084652
Brand
Sklar®
Company
SKLAR CORPORATION
Model
90-5387
Published
2016-10-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
HHWPESSARY, VAGINAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HHWPessary, VaginalObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10649111084652PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1064911108465210649111084652

GMDN Terms#

Term, Definition table
TermDefinition
Pelvic-organ-supporting pessaryA device made of rubber or soft plastics designed for insertion into the vagina to hold the uterus, bladder and/or rectum in place and help prevent prolapse (falling or sliding of the organ from its normal position into the pelvic cavity), either as a permanent or temporary treatment; it is not dedicated to bladder-only support. It is available in a variety of shapes (e.g., rings, stems) and sizes; it may be fitted for each woman individually. This is a reusable device after appropriate cleaning.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
006966006
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
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
10649111501326Sklar Instruments31-40742026-03-12
10649111294235Sklar®67-10202016-10-07
40649111231422Sklar Instruments96-11302025-11-11
40649111233150Sklar Instruments96-11402025-11-11
40649111233501Sklar Instruments96-11422025-11-11
40649111233785Sklar Instruments96-11442025-11-11
40649111234102Sklar Instruments96-11462025-11-11
50649111095045Sklar Instruments94-02902025-06-15
50649111232921Sklar Instruments941-01922025-06-15
50649111344174Sklar Instruments941-09182025-06-15
50649111400115Sklar Instruments941-12592025-06-15
50649111400122Sklar Instruments941-12602025-06-15
50649111400139Sklar Instruments941-12612025-06-15
50649111447752Sklar Instruments941-15562025-06-15
50649111447912Sklar Instruments941-16132025-06-15
50649111469907Sklar Instruments941-13202025-06-15
50649111050402Sklar Instruments96-25162025-05-29
50649111050594Sklar Instruments96-25172025-05-29
50649111081109Sklar Instruments96-26802025-05-29
50649111081499Sklar Instruments96-26822025-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09903124199456CNTRL+ Bladder Support PessaryCntrl+ Inc.HHW2026-02-22
00999999999993CNTRL+ Bladder Support PessaryCntrl+ Inc.HHW2026-02-22
09903124199692CNTRL+ Bladder Support PessaryCntrl+ Inc.HHW2026-02-22
09903124199906CNTRL+ Bladder Support PessaryCntrl+ Inc.HHW2026-02-22
00990312419945CNTRL+ Bladder Support PessaryCntrl+ Inc.HHW2025-08-22
00990312419952CNTRL+ Bladder Support PessaryCntrl+ Inc.HHW2025-08-22
00990312419969CNTRL+ Bladder Support PessaryCntrl+ Inc.HHW2025-08-22
00990312419990CNTRL+ Bladder Support PessaryCntrl+ Inc.HHW2025-08-22
00810142350334Bioteque America, Inc.Bioteque America, Inc.HHW2025-06-02
00810142350587Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350594Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350600Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350617Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350624Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350631Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350648Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350655Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350662Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350679Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350686Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350693Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350709Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350716Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350723Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350730Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350754Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350761Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350778Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350785Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350792Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29