FDA.reportPublic FDA data

KOHDENT

Primary DI
04251436907401
Brand
KOHDENT
Company
Kohdent Roland Kohler Medizintechnik GmbH & Co. KG
Model
4263
Catalog number
4263
Device description
Tampon Applicators Luniatschek
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
EIGRETRACTOR, ALL TYPES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIGRetractor, All TypesDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251436907401PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251436907401042514369074014251436907401

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose surgical spatulaA hand-held manual surgical instrument designed to manipulate tissue during various types of surgical interventions. It typically consists of a flat blunt blade (no sharp edges) that is double-ended (a blade at either end) and is not constructed for one particular part of the anatomy or clinical specialty. It is usually made of high-grade stainless steel and is available with a variety of blade designs, e.g., curved and flat or straight and flat with rounded ends; some blade types may be more right-angled. The handle will be formed from its middle section and may be more prominent/serrated. 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
G149TBSB71000TBS BASICSACME ENTERPRISE.EIG2026-05-22
G149TBSB71020TBS BASICSACME ENTERPRISE.EIG2026-05-22
G149TBSB71030TBS BASICSACME ENTERPRISE.EIG2026-05-22
G149TBSB7990TBS BASICSACME ENTERPRISE.EIG2026-05-22
00190776417567MillenniumAvalign Technologies, Inc.EIG2026-03-04
B382SD1472510000Surgical DirectSurgical Direct, Inc.EIG2026-02-16
B382SD915118280Surgical DirectSurgical Direct, Inc.EIG2026-02-16
B382SD915118290Surgical DirectSurgical Direct, Inc.EIG2026-02-16
B382SD915118300Surgical DirectSurgical Direct, Inc.EIG2026-02-16
04059453109095Hermann Medizintechnik GmbHHermann Medizintechnik GmbHEIG2026-02-13
B382SD5750050Surgical DirectSurgical Direct, Inc.EIG2026-02-10
B382SD9177181010Surgical DirectSurgical Direct, Inc.EIG2026-02-10
B382SD921052010Surgical DirectSurgical Direct, Inc.EIG2026-02-10
00888118150608RETRACTORKLS-Martin L.P.EIG2025-12-23
00810123209712Adler Instrument CompanyAdler, Inc.EIG2025-12-12
B382SD62584SS0Surgical DirectSurgical Direct, Inc.EIG2025-12-08
B382SD62585SS0Surgical DirectSurgical Direct, Inc.EIG2025-12-08
B382SD62586SS0Surgical DirectSurgical Direct, Inc.EIG2025-12-08
00810042124844OSEORTHODONTIC SUPPLY & EQUIPMENT COMPANY INCEIG2025-11-26
00810042124851OSEORTHODONTIC SUPPLY & EQUIPMENT COMPANY INCEIG2025-11-26
00810042124868OSEORTHODONTIC SUPPLY & EQUIPMENT COMPANY INCEIG2025-11-26
B382SD915100320Surgical DirectSurgical Direct, Inc.EIG2025-11-11
B382SD915100340Surgical DirectSurgical Direct, Inc.EIG2025-11-11
B382SD915100360Surgical DirectSurgical Direct, Inc.EIG2025-11-11
B382SD915100430Surgical DirectSurgical Direct, Inc.EIG2025-11-11
B382SD915100440Surgical DirectSurgical Direct, Inc.EIG2025-11-11
B382SD915100460Surgical DirectSurgical Direct, Inc.EIG2025-11-11
B382SD915100480Surgical DirectSurgical Direct, Inc.EIG2025-11-11
10190707191150Ortho Technology®Ortho Organizers, Inc.EIG2025-10-23
10190707191167Ortho Technology®Ortho Organizers, Inc.EIG2025-10-23