FDA.report

MILLENNIUM

Primary DI
00190776329488
Brand
MILLENNIUM
Company
Avalign Technologies, Inc.
Model
85-33084939
Device description
Walther Female Dilator-Catheter
Published
2023-09-28
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
00190776329488PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776329488001907763294881907763294880190776329488

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
+1(877)289-1096product.questions@avalign.com

Regulatory Flags

DUNS number
792528510
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

Other Devices From This Company

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00190776417956Millennium72-5225532B2026-03-23
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00190776417970Millennium72-4071222026-03-23
00190776417987Millennium1-2236262026-03-23
00190776417994Millennium1-1281562026-03-23
00190776418007Millennium1-OP3702026-03-23
00190776418014Millennium1-7063104R2026-03-23
00190776418021Millennium72-3160021FSYR2026-03-23
00190776418038Millennium1-8207-92026-03-23
00190776418045Millennium1-161762026-03-23
00190776418052Millennium1-3011172026-03-23
00190776418069Millennium1-4301632026-03-23
00190776418076Millennium72-31578452026-03-23
00190776418267Millennium72-24026202026-03-23

Other Devices Sharing Product Codes

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00190776417789MillenniumAvalign Technologies, Inc.HDQ2026-03-11
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00198506088247ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-01-27
00198506088254ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-01-27
00198506088261ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-01-27
00198506087981ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-01-22
00198506087998ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-01-22
00198506088001ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-01-22
00198506088018ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-01-22
00198506088025ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-01-22
00198506088032ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-01-22
00198506088049ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-01-22
04262494463143N/ADoppkon GmbH & Co. KGHDQ2025-12-04
04262494462986N/ADoppkon GmbH & Co. KGHDQ2025-12-01
04262494462993N/ADoppkon GmbH & Co. KGHDQ2025-12-01
04262494463006N/ADoppkon GmbH & Co. KGHDQ2025-12-01
04262494463013N/ADoppkon GmbH & Co. KGHDQ2025-12-01
04262494463020N/ADoppkon GmbH & Co. KGHDQ2025-12-01
00190776411671MillenniumAvalign Technologies, Inc.HDQ2025-09-25
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