FDA.reportPublic FDA data

ComforTen® 60-hole covered tray

Primary DI
00365044000080
Brand
ComforTen® 60-hole covered tray
Company
Jubilant Hollisterstier LLC
Model
8000001372
Catalog number
8000001372
Device description
60 hole test tray.
Published
2026-03-02
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
LDGKit, Earmold, Impression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDGKit, Earmold, ImpressionEar, Nose, Throat1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K953939000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K953939000QUINTESTBayer Corp.1995-11-13SCL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00365044000080PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00365044000080003650440000803650440000800365044000080

GMDN Terms#

Term, Definition table
TermDefinition
Allergy testing lancetA sterile device with a sharp triangular cutting edge at the distal end designed to manually breach the epidermis to facilitate the diagnosis of allergic reactions in skin allergy testing performed by an allergist or other healthcare professional. It is held between the fingertips and pressed transiently, but firmly (not jabbed), at right angles through a drop of an allergen extract into the flexor side of the forearm of a suspected allergic individual. The tip penetrates only the most superficial layers of the skin allowing a small volume of the allergen extract to enter the skin and diffuse into the skin layers below. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800.495.7437HollisterStier@jubl.com

Regulatory Flags#

DUNS number
119241112
Device count
1
Combination product
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00365044000004Quintest® Multiple Skin Test Device8392ZA8392ZA2024-11-15
00365044000011ComforTen® Multiple Skin Test System80000000021800000000212024-11-15
00365044000028Quintip® Skin Test Device8400ZA8400ZA2024-11-15
00365044000035Prick Lancetter™8375ZA8375ZA2024-11-15
00365044000042Skin Test Reservoirs8924ZA8924ZA2024-11-15
10365044000001Quintest® Multiple Skin Test Device8392ZA8392ZA2024-11-15
10365044000018ComforTen® Multiple Skin Test System80000000021800000000212024-11-15
10365044000025Quintip® Skin Test Device8400ZA8400ZA2024-11-15
10365044000032Prick Lancetter™8375ZA8375ZA2024-11-15
10365044000049Skin Test Reservoirs8924ZA8924ZA2024-11-15
00365044000059ComforTen® 30-hole covered tray8406ZA8406ZA2024-11-15
00365044000066ComforTen® 60-hole covered tray8407ZA8407ZA2024-11-15
00365044000073Quintest® Covered Tray8930ZA8930ZA2024-11-15

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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E2392956M1Otoform® A softXDreve Otoplastik GmbHLDG2025-01-20
E2393206M1Otoform® A softDreve Otoplastik GmbHLDG2025-01-20
E2395041Otoform® KcDreve Otoplastik GmbHLDG2025-01-13
E2398802AU1Otoform® A softX Dreve Otoplastik GmbHLDG2024-03-13
E2398802ST1Otoform® A softX Dreve Otoplastik GmbHLDG2024-03-13
E2398802M1Otoform® A softXDreve Otoplastik GmbHLDG2023-12-18
E23988021Otoform® A softX Dreve Otoplastik GmbHLDG2023-10-31
EPRCA0010200otosil IS-2pro3dure medical GmbHLDG2023-10-18
EPRCA0011000otosil PS-1pro3dure medical GmbHLDG2023-10-18
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