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Ureteral Dilator With AQ® Hydrophilic Coating With Modified Taper

EUDAMEDFDA UDI

Class I (EU MDR)

Ref AQ-076012-TPRef JCD6.0-35-20-HCRef JCD14.0-38-20-HCRef JCD5.0-38-20-HC

by Cook Incorporated

Identity

Trade Name
Ureteral Dilator With AQ® Hydrophilic Coating With Modified Taper EUDAMED
Cook FDA UDI
Generic Name
Fascial tissue dilator, single-use FDA UDI
Endoscopic-access dilator, single-use FDA UDI
Device Name
Ureteral Dilator [With AQ® Hydrophilic Coating With Modified Taper; Set Dilators With AQ® Hydrophilic Coating; S~Curve® with AQ® Hydrophilic Coating] EUDAMED
Dilator with Hydrophilic Coating EUDAMED
Dilator With AQ, Hydrophilic Coating FDA UDI
Ureteral Dilator With AQ, Hydrophilic Coating With Modified Taper FDA UDI
Model / Reference
AQ-076012-TP EUDAMED
JCD6.0-35-20-HC EUDAMED
JCD14.0-38-20-HC EUDAMED
JCD5.0-38-20-HC EUDAMED
G10283 FDA UDI
G10284 FDA UDI
G17636 FDA UDI
G10293 FDA UDI
Description
Dilator With AQ, Hydrophilic Coating FDA UDI
Ureteral Dilator With AQ, Hydrophilic Coating With Modified Taper FDA UDI

Identifiers

Catalog Number
JCD5.0-38-20-HC FDA UDI
JCD6.0-35-20-HC FDA UDI
AQ-076012-TP FDA UDI
JCD14.0-38-20-HC FDA UDI
Primary DI / UDI-DI
00827002176362 EUDAMEDFDA UDI
00827002102835 EUDAMEDFDA UDI
00827002102842 EUDAMEDFDA UDI
00827002102934 EUDAMEDFDA UDI
Basic UDI-DI
0827002CINC050-124_A1YQ EUDAMED
0827002CINC014-031_A1XH EUDAMED
FDA Product Code
FGE FDA UDI
KOE FDA UDI
EMDN Code
U03010202 URETERAL DILATORS EUDAMED
C9002 VASCULAR AND FASCIAL DILATORS EUDAMED
GMDN Term
Fascial tissue dilator, single-use FDA UDI
Endoscopic-access dilator, single-use FDA UDI

Classification

Device Class
Class I EUDAMED
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
876.5010 FDA UDI
876.5520 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Ureteral introduction sheath

Ureteral Dilator With AQ® Hydrophilic Coating With Modified Taper by Cook Incorporated — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID

Similar devices

Also classified as Ureteral introduction sheath.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cook Incorporated
EUDAMED SRN
US-MF-000003180
Authorised Representative
COOK MEDICAL EUROPE LIMITED IE-AR-000000907

Sources (8)

  • EUDAMED da6e0fe0-f936-4f0c-a579-0fc273b610af 61 fields · synced Jul 18, 2026
  • FDA UDI f4589115-aea4-4cfa-90ac-91ff71502b38 36 fields · synced May 29, 2026
  • FDA UDI ab506be7-3a27-454c-b466-20860241ae10 36 fields · synced May 30, 2026
  • FDA UDI de6654cd-543a-4c3d-9d68-436ff000eda4 36 fields · synced May 30, 2026
  • FDA UDI e12c2249-b2ef-4298-b6d6-9f2e37e922a7 36 fields · synced May 30, 2026
  • EUDAMED 2fd00719-9349-4314-9276-dda19f7ba8b2 61 fields · synced Jul 9, 2026
  • EUDAMED 92406ebf-2c46-4ae2-968d-f5c25d13a3a2 61 fields · synced Jul 16, 2026
  • EUDAMED 0530f4b1-d364-4349-b729-fcf430e12f52 61 fields · synced Jul 16, 2026