FDA.reportPublic FDA data

N/A

Primary DI
04262494460791
Brand
N/A
Company
Doppkon GmbH & Co. KG
Model
A-100-080
Catalog number
A-100-080
Device description
Dilator Conical TubesID 4.2mm, OD 5.1mm, WL 170mm
Published
2025-09-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HDXDilator, Vaginal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDXDilator, VaginalObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04262494460791PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04262494460791042624944607914262494460791

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic-access dilator, reusableA device intended to be used to dilate a body lumen or access channel to facilitate the introduction of endoscopic instruments percutaneously (through the skin) or through a natural orifice (e.g., urethra). It may be a flexible or rigid rod/tube with a tapered distal tip. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
314157821
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04262494460029N/AA-001-450A-001-4502025-12-04
04262494460036N/AA-001-451A-001-4512025-12-04
04262494460043N/AA-001-452A-001-4522025-12-04
04262494460050N/AA-001-453A-001-4532025-12-04
04262494460067N/AA-001-454A-001-4542025-12-04
04262494460074N/AA-001-455A-001-4552025-12-04
04262494460081N/AA-001-456A-001-4562025-12-04
04262494460098N/AA-001-457A-001-4572025-12-04
04262494460104N/AA-001-458A-001-4582025-12-04
04262494460111N/AA-001-459A-001-4592025-12-04
04262494460128N/AA-001-460A-001-4602025-12-04
04262494460135N/AA-001-461A-001-4612025-12-04
04262494460142N/AA-001-462A-001-4622025-12-04
04262494460159N/AA-001-463A-001-4632025-12-04
04262494462962N/AA-001-337A-001-3372025-12-04
04262494462979N/AA-001-318A-001-3182025-12-04
04262494463051N/AA-100-520A-100-5202025-12-04
04262494463112N/AA-001-338A-001-3382025-12-04
04262494463129N/AA-001-339A-001-3392025-12-04
04262494463143N/AA-100-735A-100-7352025-12-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810142352307Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-30
00810142352215Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-29
00810142352222Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-29
00810142352239Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-29
00810142352246Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-29
00810142352260Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-29
00810142352277Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-29
00810142352284Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-29
00810142352291Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-29
00810142352314Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-12
00810142352253Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-08
00850005838029Intimate RosePLUS EV HOLDINGS INC.HDX2024-12-10
00850005838036Intimate RosePLUS EV HOLDINGS INC.HDX2024-12-10
00850005838043Intimate RosePLUS EV HOLDINGS INC.HDX2024-12-10
00850005838050Intimate RosePLUS EV HOLDINGS INC.HDX2024-12-10
00850005838067Intimate RosePLUS EV HOLDINGS INC.HDX2024-12-10
00850005838074Intimate RosePLUS EV HOLDINGS INC.HDX2024-12-10
00850005838081Intimate RosePLUS EV HOLDINGS INC.HDX2024-12-10
00850005838098Intimate RosePLUS EV HOLDINGS INC.HDX2024-12-10
00850005838104Intimate RosePLUS EV HOLDINGS INC.HDX2024-12-10
00850005838111Intimate RosePLUS EV HOLDINGS INC.HDX2024-12-10
00850005838128Intimate RosePLUS EV HOLDINGS INC.HDX2024-12-10
00860012225002Hope&Her Vaginal DilatorsLUJENA, INC.HDX2024-11-15
B8034701660ORTHOMEDORTHO-MED, INC.HDX2024-05-17
04719894432236Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.HDX2024-04-08
04719894432243Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.HDX2024-04-08
04719894432250Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.HDX2024-04-08
04719894432267Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.HDX2024-04-08
04719894432274Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.HDX2024-04-08
04719894432281Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.HDX2024-04-08