FDA.reportPublic FDA data

Hayden Medical

Primary DI
00840319750544
Brand
Hayden Medical
Company
Hayden Medical, Inc.
Model
365-201
Catalog number
365-201
Device description
"Hulka Uterine Mobilizer/Tenaculum 11-1/4"" (28.1cm), with insulated sound"
Published
2023-03-21
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
PUATenaculum, uterine, exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUATenaculum, Uterine, ExemptObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840319750544PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840319750544008403197505448403197505440840319750544

GMDN Terms#

Term, Definition table
TermDefinition
Uterine tenaculumA hand-held manual surgical instrument with hooks at the distal end used for grasping and/or manipulating uterine tissue during a surgical intervention or examination of the uterus and associated structures (e.g., cervix). It typically has a scissors-like, self-retaining design with ring handles and is made of high-grade stainless steel. It is available in various sizes. 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
Premarket 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
05010058078321InstrapacROBINSON HEALTHCARE LIMITEDPUA2025-05-21
05010058079571InstrapacROBINSON HEALTHCARE LIMITEDPUA2025-05-21
05010058178328InstrapacROBINSON HEALTHCARE LIMITEDPUA2025-05-21
05010058179578InstrapacROBINSON HEALTHCARE LIMITEDPUA2025-05-21
00840183515928BR Surgical, LLCBR Surgical, LLCPUA2024-07-23
00840183518202BR Surgical, LLCBR Surgical, LLCPUA2024-07-23
00840319748527Hayden MedicalHayden Medical, Inc.PUA2023-03-21
00840319748534Hayden MedicalHayden Medical, Inc.PUA2023-03-21
00840319749715Hayden MedicalHayden Medical, Inc.PUA2023-03-21
00840319749722Hayden MedicalHayden Medical, Inc.PUA2023-03-21
00840319749739Hayden MedicalHayden Medical, Inc.PUA2023-03-21
00840319749746Hayden MedicalHayden Medical, Inc.PUA2023-03-21
00840319749753Hayden MedicalHayden Medical, Inc.PUA2023-03-21
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00840319749814Hayden MedicalHayden Medical, Inc.PUA2023-03-21
00840319749821Hayden MedicalHayden Medical, Inc.PUA2023-03-21
00840319749838Hayden MedicalHayden Medical, Inc.PUA2023-03-21
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00840319750551Hayden MedicalHayden Medical, Inc.PUA2023-03-21
00840319752661Hayden MedicalHayden Medical, Inc.PUA2023-03-21
00840319752678Hayden MedicalHayden Medical, Inc.PUA2023-03-21
00840319733325Hayden MedicalHayden Medical, Inc.PUA2022-09-12
00840319733387Hayden MedicalHayden Medical, Inc.PUA2022-09-12
00840319733394Hayden MedicalHayden Medical, Inc.PUA2022-09-12
00840319733400Hayden MedicalHayden Medical, Inc.PUA2022-09-12
00840319733417Hayden MedicalHayden Medical, Inc.PUA2022-09-12
00840319733424Hayden MedicalHayden Medical, Inc.PUA2022-09-12