FDA.reportPublic FDA data

Hayden Medical

Primary DI
00840319743140
Brand
Hayden Medical
Company
Hayden Medical, Inc.
Model
202-160
Catalog number
202-160
Device description
"Jennings Mouth Gag, adult size, 6"" (15cm) wide"
Published
2023-03-14
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
KBNGAG, MOUTH

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KBNGag, MouthEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840319743140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840319743140008403197431408403197431400840319743140

GMDN Terms#

Term, Definition table
TermDefinition
Frame/rail/pole device holderA clamp-like device intended to be affixed to a bed frame, standard rail or standing pole [e.g., intravenous (IV) pole] to provide a means to fix/mount a medical device (e.g., suction/irrigation pump, display monitor), or other non-medical device, to the support. It typically has a gripping profile that is compatible with the device it is intended to fit. 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
00190776418489MillenniumAvalign Technologies, Inc.KBN2026-04-06
14026704810069PILLINGTELEFLEX INCORPORATEDKBN2022-12-08
14026704810076PILLINGTELEFLEX INCORPORATEDKBN2022-12-08
14026704810083PILLINGTELEFLEX INCORPORATEDKBN2022-12-08
14026704810090PILLINGTELEFLEX INCORPORATEDKBN2022-12-08
14026704810106PILLINGTELEFLEX INCORPORATEDKBN2022-12-08
14026704810113PILLINGTELEFLEX INCORPORATEDKBN2022-12-08
14026704810120PILLINGTELEFLEX INCORPORATEDKBN2022-12-08
ESAM4011541STOMA®Storz am Mark GmbHKBN2022-11-07
ESAM3725121STOMA®Storz am Mark GmbHKBN2020-08-27
ESAM3740111STOMA®Storz am Mark GmbHKBN2020-08-27
ESAM3740141STOMA®Storz am Mark GmbHKBN2020-08-27
ESAM4033001STOMA®Storz am Mark GmbHKBN2020-08-27
ESAM4033011STOMA®Storz am Mark GmbHKBN2020-08-27
ESAM4033021STOMA®Storz am Mark GmbHKBN2020-08-27
ESAM4033031STOMA®Storz am Mark GmbHKBN2020-08-27
10889950015695Hu-FriedyHU-FRIEDY MFG. CO., LLCKBN2020-08-14
10889950015701Hu-FriedyHU-FRIEDY MFG. CO., LLCKBN2020-08-14
10889950015718Hu-FriedyHU-FRIEDY MFG. CO., LLCKBN2020-08-14
10381780448822Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKBN2018-10-23
14026704630742PILLINGTELEFLEX INCORPORATEDKBN2018-10-22
24026704600322PillingTELEFLEX INCORPORATEDKBN2018-09-15
24026704600339PillingTELEFLEX INCORPORATEDKBN2018-09-15
10381780506485Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKBN2018-09-12
10381780507857Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKBN2018-09-12
10381780487807Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKBN2018-08-29
10381780487814Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKBN2018-08-20
10381780487821Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKBN2018-08-20
10381780487845Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKBN2018-08-20
10381780437963Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKBN2018-08-16