FDA.reportPublic FDA data

Hysolate

Primary DI
17630392900482
Brand
Hysolate
Company
Dent4You AG
Model
H01415
Device description
Ora-Shield Dental Dam Napkins Adult (6 x 6), 50 pcs
Published
2023-02-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
KHRAbsorber, Saliva, Paper

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KHRAbsorber, Saliva, PaperDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630392900485PrimaryGS10
17630392900482Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630392900485076303929004857630392900485
1763039290048217630392900482

GMDN Terms#

Term, Definition table
TermDefinition
Saliva absorbentA non-sterile device designed to absorb moisture from the oral cavity during a dental procedure. Also known as a saliva absorber, it can be in a variety of shapes and sizes and is typically made of paper, cotton, or polymeric web, and may have a high-absorbent core. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
480152811
Device count
50
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630243660995Alpen Diamonds60032007600320072026-09-04
07630243661237Alpen Diamonds60032031600320312026-09-04
07630243662470Alpen Diamonds60032155600321552026-09-04
07630243662494Alpen Diamonds60032157600321572026-09-04
07630243662517Alpen Diamonds60032159600321592026-09-04
07630243662531Alpen Diamonds60032161600321612026-09-04
07630243662555Alpen Diamonds60032163600321632026-09-04
07630243662579Alpen Diamonds60032165600321652026-09-04
07630243662593Alpen Diamonds60032167600321672026-09-04
07630243662616Alpen Diamonds60032169600321692026-09-04
07630243662630Alpen Diamonds60032171600321712026-09-04
07630243662654Alpen Diamonds60032173600321732026-09-04
07630243662678Alpen Diamonds60032175600321752026-09-04
07630243662692Alpen Diamonds60032177600321772026-09-04
07630243662715Alpen Diamonds60032179600321792026-09-04
07630243662739Alpen Diamonds60032181600321812026-09-04
07630243662753Alpen Diamonds60032183600321832026-09-04
07630243662777Alpen Diamonds60032185600321852026-09-04
07630243662791Alpen Diamonds60032187600321872026-09-04
07630243662814Alpen Diamonds60032189600321892026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456225165JMUJMU DENTAL, INCKHR2026-09-18
00840456201428JMUJMU DENTAL, INCKHR2026-07-08
00840456217696JMUJMU DENTAL, INCKHR2026-06-05
00840456222188JMUJMU DENTAL, INCKHR2026-06-05
00840456222195JMUJMU DENTAL, INCKHR2026-06-05
00840456223000JMUJMU DENTAL, INCKHR2026-06-05
00840456223017JMUJMU DENTAL, INCKHR2026-06-05
00840456201756JMUJMU DENTAL, INCKHR2026-05-27
00840456201763JMUJMU DENTAL, INCKHR2026-05-27
00840456201770JMUJMU DENTAL, INCKHR2026-05-27
00840456201787JMUJMU DENTAL, INCKHR2026-05-27
00840456201794JMUJMU DENTAL, INCKHR2026-05-27
00840456221020JMUJMU DENTAL, INCKHR2026-05-27
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