FDA.report

Millennium

Primary DI
00190776299668
Brand
Millennium
Company
AVALIGN TECHNOLOGIES, INC.
Model
72-3434003
Device description
ELLIK RUBBER BALL ONLY
Published
2023-06-23
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
FFDEvacuator, bladder, manually operated

Product Code Classifications

CodeDeviceSpecialtyClass
FFDEvacuator, Bladder, Manually OperatedGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190776299668PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776299668001907762996681907762996680190776299668

GMDN Terms

TermDefinition
Bladder evacuator, reusableA hand-operated device that is attached to a resectoscope and used to suction tissue and body fluids that are released during a transurethral resection (TUR) procedure. It typically consists of a glass or plastic container, a squeeze bulb, tubing and a connector/adaptor for connection to the resectoscope. It is filled with sterile water and vigorously squeezed to force the water through the resectoscope to irrigate and evacuate tissue fragments, blood clots, or calculi from the urinary bladder; these are caught and trapped within the evacuator so as not to be returned to the bladder when the device is squeezed again. Commonly known as an Ellik evacuator. 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

Primary DIBrandModelCatalogPublished
00190776417895Millennium72-53030126C2026-03-23
00190776417901Millennium72-3280326I2026-03-23
00190776417918Millennium72-235613LH2026-03-23
00190776417925Millennium72-3752532026-03-23
00190776417932Millennium100-S03681TRS2026-03-23
00190776417949Millennium72-235633LH2026-03-23
00190776417956Millennium72-5225532B2026-03-23
00190776417963Millennium72-2407032026-03-23
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

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00810143891256Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FFD2024-09-27
26936881168783Wellead EvacuatorWell Lead Medical Co.,LtdFFD2024-01-19
26936881168790Wellead EvacuatorWell Lead Medical Co.,LtdFFD2024-01-19
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05060460848050EnteralGBUK ENTERAL LIMITEDFFD2022-10-19
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05060590889428EnteralGBUK ENTERAL LIMITEDFFD2022-10-19
05060590889442EnteralGBUK ENTERAL LIMITEDFFD2022-10-19
05060590880807EnteralGBUK ENTERAL LIMITEDFFD2022-10-14
05060590880838EnteralGBUK ENTERAL LIMITEDFFD2022-10-14
05060590880869EnteralGBUK ENTERAL LIMITEDFFD2022-10-14
05060590880890EnteralGBUK ENTERAL LIMITEDFFD2022-10-14
05060590880937EnteralGBUK ENTERAL LIMITEDFFD2022-10-14
00850033250930Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FFD2022-06-08
00850033250947Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FFD2022-06-08
06972261829048VESCOUcomfor Scientific Co.,LtdFFD2022-05-16
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10350770469130AVANOSAvanos Medical, Inc.FFD2020-02-17