FDA.reportPublic FDA data

KOHDENT

Primary DI
04251436929014
Brand
KOHDENT
Company
Kohdent Roland Kohler Medizintechnik GmbH & Co. KG
Model
8137
Catalog number
8137
Device description
Iliac Retractor TESSIER 59 x 50 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

Contact Domains#

Product Codes#

Code, Name table
CodeName
EMHFORCEPS, RONGEUR, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMHForceps, Rongeur, SurgicalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251436929014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251436929014042514369290144251436929014

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held surgical retractor, reusableA hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04251436943492KOHDENT670067002023-11-28
04251436915819KOHDENT573957392021-09-22
04251436915826KOHDENT574057402021-09-22
04251436915833KOHDENT574157412021-09-22
04251436918094KOHDENT616361632021-09-22
04251436918100KOHDENT616661662021-09-22
04251436918179KOHDENT620962092021-09-22
04251436918186KOHDENT621062102021-09-22
04251436918834KOHDENT635863582021-09-22
04251436921209KOHDENT679267922021-09-22
04251436924217KOHDENT733573352021-09-22
04251436924224KOHDENT733673362021-09-22
04251436924231KOHDENT733773372021-09-22
04251436924392KOHDENT737073702021-09-22
04251436924408KOHDENT737173712021-09-22
04251436925559KOHDENT751075102021-09-22
04251436928604KOHDENT799279922021-09-22
04251436929113KOHDENT814781472021-09-22
04251436929120KOHDENT814881482021-09-22
04251436932281KOHDENT767076702021-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810158219229PRINCETONPrinceton Medical Group, Inc.EMH2026-03-12
00810158219076PRINCETONPrinceton Medical Group, Inc.EMH2026-03-11
00810158219083PRINCETONPrinceton Medical Group, Inc.EMH2026-03-11
00810158219120PRINCETONPrinceton Medical Group, Inc.EMH2026-03-11
04059453090195Hermann Medizintechnik GmbHHermann Medizintechnik GmbHEMH2026-01-29
D9281009301850RONGEUR DOUBLE ACTION RUSKIN CURVED 18CM, 5MMW.H. Holden, Inc.EMH2026-01-06
D9281009302390RONGEUR DOUBLE ACTION RUSKIN CURVED 23CM, 6MMW.H. Holden, Inc.EMH2026-01-06
B7688441020Buxton BioMedicalBuxton Biomedical IncEMH2025-12-31
B7688457751630Buxton BioMedicalBuxton Biomedical IncEMH2025-12-31
B76885362280Buxton BioMedicalBuxton Biomedical IncEMH2025-12-31
B76885362360Buxton BioMedicalBuxton Biomedical IncEMH2025-12-31
08809596474019Kerrison Rotating Rongeur ShaftHankil Tech Medical Co., Ltd.EMH2025-12-16
08809596474071Endo Scope Kerrision Rotating Rongeur ShaftHankil Tech Medical Co., Ltd.EMH2025-12-16
08809596474095Endo Scope Kerrision Rotating Rongeur ShaftHankil Tech Medical Co., Ltd.EMH2025-12-16
08809596474996Kerrison Rotating Rongeur HandleHankil Tech Medical Co., Ltd.EMH2025-12-16
B356ED107160American MedicalsAmerican MedicalsEMH2025-12-03
B76884332520Buxton BioMedicalBuxton Biomedical IncEMH2025-11-13
B76885300040Buxton BioMedicalBuxton Biomedical IncEMH2025-11-13
00198506084522ELMED INCORPORATEDELMED INCORPORATEDEMH2025-08-11
00198506084539ELMED INCORPORATEDELMED INCORPORATEDEMH2025-08-11
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00198506084584ELMED INCORPORATEDELMED INCORPORATEDEMH2025-08-11
00198506084591ELMED INCORPORATEDELMED INCORPORATEDEMH2025-08-11
00198506084607ELMED INCORPORATEDELMED INCORPORATEDEMH2025-08-11
B76884850320Buxton BioMedicalBuxton Biomedical IncEMH2025-07-30
B76884850420Buxton BioMedicalBuxton Biomedical IncEMH2025-07-30
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B76884852320Buxton BioMedicalBuxton Biomedical IncEMH2025-07-30