FDA.report

Medicon

Primary DI
04046826067021
Brand
Medicon
Company
Medicon eG. Chirurgiemechaniker-Genossenschaft
Model
52.37.17
Catalog number
52.37.17
Device description
Hank uter dilator d/e size 17/18
Published
2020-09-24
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
HDQDILATOR, CERVICAL, FIXED SIZE

Product Code Classifications

CodeDeviceSpecialtyClass
HDQDilator, Cervical, Fixed SizeObstetrics/Gynecology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046826067021PrimaryGS10

Alternate GTIN/UPC/EAN values are derived from GS1 digit structure for lookup convenience. Do not treat derived UPC-A or EAN-13 values as separate FDA identifiers. GTIN-14 values with indicator digits 1-9 usually represent packaging levels, cases, pallets, or variable-measure items and are not converted to UPC-A/EAN-13 here.

Alternate GTIN / UPC / EAN Codes

Source identifierSource lengthGTIN-14 normalizedIndicatorEAN-13Conversion note
04046826067021140404682606702104046826067021Indicator 0 allows EAN-13 conversion; UPC-A requires prefix 00.

GMDN Terms

TermDefinition
Vaginal dilatorA firm rod-like instrument designed to mechanically enlarge the vagina during examination, treatment, and/or during surgical procedures. It can also be inserted into the vagina and worn for prescribed periods to maintain vaginal patency after surgery (e.g., transgender vaginoplasty) or radiation treatments, or to stretch the vaginal orifice (the introitus) when it is unusually narrow due to a birth defect or vaginismus (the inability of the vaginal sphincter to relax). The device is typically available in a set of graduated sizes and the user is typically instructed to begin with the smallest diameter, increasing in size until satisfactory patency is achieved. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+490746220090sales@medicon.de

Regulatory Flags

DUNS number
315492330
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
false
Sterilization required before use
true

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04046826445928Medicon Tray906.91.22906.91.222026-03-20
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04046826055493Medicon Tray49.97.8249.97.822026-03-19
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04046826472061Medicon58.82.2658.82.262026-03-19
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04046826492632Medicon70.46.2570.46.252026-03-19
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04046826118327Medicon68.03.5268.03.522026-02-27
04046826118341Medicon68.03.5468.03.542026-02-27
04046826532871Medicon68.83.47A68.83.47A2026-01-19
04046826533427Medicon68.83.44A68.83.44A2026-01-19
04046826055158Medicon Tray49.97.1249.97.122025-12-17
04046826068424Medicon52.70.7152.70.712025-12-17

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