FDA.reportPublic FDA data

KOHDENT

Primary DI
04251436915345
Brand
KOHDENT
Company
Kohdent Roland Kohler Medizintechnik GmbH & Co. KG
Model
5621
Catalog number
5621
Device description
Needle Holders Castro. str. 18 cm
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
DZMNEEDLE, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZMNeedle, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251436915345PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251436915345042514369153454251436915345

GMDN Terms#

Term, Definition table
TermDefinition
Suturing needle holder, reusableA hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. It is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. Some types may utilize inserts made of hard materials (e.g., carbide) and include scissor blades. 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
00810126508218Essentials By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCDZM2026-03-11
00810126508225Essentials By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCDZM2026-03-11
50192253037430MonojectCardinal Health 200, LLCDZM2026-02-10
50192253037454MonojectCardinal Health 200, LLCDZM2026-02-10
50192253037461MonojectCardinal Health 200, LLCDZM2026-02-10
50192253037478MonojectCardinal Health 200, LLCDZM2026-02-10
50192253037492MonojectCardinal Health 200, LLCDZM2026-02-10
50192253037515MonojectCardinal Health 200, LLCDZM2026-02-10
50192253037522MonojectCardinal Health 200, LLCDZM2026-02-10
50192253037539MonojectCardinal Health 200, LLCDZM2026-02-10
00840456213629JMUJMU DENTAL, INCDZM2025-12-22
00840456213636JMUJMU DENTAL, INCDZM2025-12-22
00840456213643JMUJMU DENTAL, INCDZM2025-12-22
00840456213650JMUJMU DENTAL, INCDZM2025-12-22
00841336101029Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCDZM2025-11-11
00842517112360Karl SchumacherKarl Schumacher Dental, LLCDZM2025-07-08
00842517112384Karl SchumacherKarl Schumacher Dental, LLCDZM2025-07-08
00842517112421Karl SchumacherKarl Schumacher Dental, LLCDZM2025-07-08
00842517112476Karl SchumacherKarl Schumacher Dental, LLCDZM2025-07-08
00842517112483Karl SchumacherKarl Schumacher Dental, LLCDZM2025-07-08
08800123817903V-JectVERICOM CO., LTD.DZM2025-06-25
08800123817941V-JectVERICOM CO., LTD.DZM2025-06-25
08800123817965V-JectVERICOM CO., LTD.DZM2025-06-25
06936018502202baixinAnhui Kangda Medical Products Co.,Ltd.DZM2025-05-28
06936018502257baixinAnhui Kangda Medical Products Co.,Ltd.DZM2025-05-28
G001HSB1071100House BrandChengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.DZM2024-09-06
86974456210057CICADAFoshan Cicada Dental Instrument Co., Ltd.DZM2024-08-10
86974456210217CICADAFoshan Cicada Dental Instrument Co., Ltd.DZM2024-08-10
86974456210224CICADAFoshan Cicada Dental Instrument Co., Ltd.DZM2024-08-10
G001HSB1071102House Brand DentistryChengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.DZM2024-06-05