FDA.reportPublic FDA data

Hayden Medical

Primary DI
00840319733639
Brand
Hayden Medical
Company
Hayden Medical, Inc.
Model
PDS-C
Catalog number
PDS-C
Device description
Flexible Silicone Vaginal Dilator (large) Set, Vaginal-Hymenal, set of 4
Published
2022-09-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HDXDILATOR, VAGINAL

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130273000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130273000PANPAC VAGINAL DILATORSPanpac Medical Corporation2013-08-08HDX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840319733639PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840319733639008403197336398403197336390840319733639

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal dilatorA firm rod-like instrument designed to mechanically enlarge the vagina during examination, treatment, and/or during surgical procedures. It can also be inserted into the vagina and worn for prescribed periods to maintain vaginal patency after surgery (e.g., transgender vaginoplasty) or radiation treatments, or to stretch the vaginal orifice (the introitus) when it is unusually narrow due to a birth defect or vaginismus (the inability of the vaginal sphincter to relax). The device is typically available in a set of graduated sizes and the user is typically instructed to begin with the smallest diameter, increasing in size until satisfactory patency is achieved. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(661)296-7200info@haydenmedical.com

Regulatory Flags#

DUNS number
618214410
Device count
1
DM exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840319759028Hayden MedicalE5-6459E5-64592026-05-15
00840319759004Hayden MedicalE7-2385E7-23852026-05-13
00840319759011Hayden Medical405-450S405-450S2026-05-01
00840319757987Hayden Medical405-463CS405-463CS2026-04-23
00840319758977Hayden Medical405-466CS405-466CS2026-04-23
00840319758984Hayden Medical405-470405-4702026-04-22
00840319758991Hayden Medical405-465CS405-465CS2026-04-22
00840319757994Hayden Medical405-465CS405-465CS2025-04-30
00840319756966Hayden Medical405-470405-4702024-04-12
00840319758892Hayden MedicalE7-0226E7-02262026-03-31
00840319758922Hayden MedicalE7-2234E7-22342026-03-31
00840319758939Hayden Medical210-179210-1792026-03-31
00840319758885Hayden MedicalE5-6271E5-62712026-03-27
00840319758854Hayden MedicalE5-6561E5-65612026-03-06
00840319758861Hayden Medical210-212210-2122026-03-05
00840319758878Hayden Medical210-213210-2132026-03-05
00840319758700Hayden Medical105-432-14105-432-142026-02-06
00840319758663Hayden MedicalE3-2623TE3-2623T2026-01-30
00840319737798Hayden Medical105-432105-4322023-03-17
00840319733134Hayden Medical105-432-10105-432-102022-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04262494460791N/ADoppkon GmbH & Co. KGHDX2025-09-10
00810142352307Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-30
00810142352215Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-29
00810142352222Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-29
00810142352239Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-29
00810142352246Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-29
00810142352260Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-29
00810142352277Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-29
00810142352284Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-29
00810142352291Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-29
00810142352314Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-12
00810142352253Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-08
00850005838029Intimate RosePLUS EV HOLDINGS INC.HDX2024-12-10
00850005838036Intimate RosePLUS EV HOLDINGS INC.HDX2024-12-10
00850005838043Intimate RosePLUS EV HOLDINGS INC.HDX2024-12-10
00850005838050Intimate RosePLUS EV HOLDINGS INC.HDX2024-12-10
00850005838067Intimate RosePLUS EV HOLDINGS INC.HDX2024-12-10
00850005838074Intimate RosePLUS EV HOLDINGS INC.HDX2024-12-10
00850005838081Intimate RosePLUS EV HOLDINGS INC.HDX2024-12-10
00850005838098Intimate RosePLUS EV HOLDINGS INC.HDX2024-12-10
00850005838104Intimate RosePLUS EV HOLDINGS INC.HDX2024-12-10
00850005838111Intimate RosePLUS EV HOLDINGS INC.HDX2024-12-10
00850005838128Intimate RosePLUS EV HOLDINGS INC.HDX2024-12-10
00860012225002Hope&Her Vaginal DilatorsLUJENA, INC.HDX2024-11-15
B8034701660ORTHOMEDORTHO-MED, INC.HDX2024-05-17
04719894432236BiotequeBioteque Taiwan Ltd.HDX2024-04-08
04719894432243BiotequeBioteque Taiwan Ltd.HDX2024-04-08
04719894432250BiotequeBioteque Taiwan Ltd.HDX2024-04-08
04719894432267BiotequeBioteque Taiwan Ltd.HDX2024-04-08
04719894432274BiotequeBioteque Taiwan Ltd.HDX2024-04-08