FDA.report

KOHDENT

Primary DI
04251436929366
Brand
KOHDENT
Company
Kohdent Roland Kohler Medizintechnik GmbH & Co. KG
Model
8172
Catalog number
8172
Device description
Bendable retractor, concave 15/17 mm
Published
2021-08-30
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
false

Related Records

Contact Domains

Product Codes

CodeName
HXRSPATULA, ORTHOPEDIC

Product Code Classifications

CodeDeviceSpecialtyClass
HXRSpatula, OrthopedicGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04251436929366PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04251436929366042514369293664251436929366

GMDN Terms

TermDefinition
Hand-held dental retractorA hand-held, non-self-retaining dental instrument intended to be used to manually displace soft tissues of the oral cavity to improve their visualization and access, and to afford them protection during oral surgical procedures. It is typically a metallic device and includes a shaped/hooked blade with a handle/holding portion. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+497771649990info@kohler-medizintechnik.de

Regulatory Flags

DUNS number
324006097
Device count
1
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

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08800017284620LOSPA IS Spinal SystemCorentec Co., LtdHXR2022-10-20
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00681490912242Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXR2022-10-14
00840319718230Hayden MedicalHayden Medical, Inc.HXR2022-08-03
00840319701492Hayden MedicalHayden Medical, Inc.HXR2022-07-22
00840319701508Hayden MedicalHayden Medical, Inc.HXR2022-07-22
04251436928604KOHDENTKohdent Roland Kohler Medizintechnik GmbH & Co. KGHXR2021-09-22
04251436915178KOHDENTKohdent Roland Kohler Medizintechnik GmbH & Co. KGHXR2021-08-30
04251436921902KOHDENTKohdent Roland Kohler Medizintechnik GmbH & Co. KGHXR2021-08-30
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04251436929359KOHDENTKohdent Roland Kohler Medizintechnik GmbH & Co. KGHXR2021-08-30
04251436930638KOHDENTKohdent Roland Kohler Medizintechnik GmbH & Co. KGHXR2021-08-30
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M36841601GrafcoGF HEALTH PRODUCTS, INC.HXR2021-06-03
00840314220134gSourceGSOURCE LLCHXR2020-11-02
00840314220202gSourceGSOURCE LLCHXR2020-11-02