FDA.reportPublic FDA data

Peditrol

Primary DI
06009900408316
Brand
Peditrol
Company
WISMED PL SP Z O O
Model
1
Device description
Peditrol is a foot-operated irrigation system that is used during Ureterorenoscopy to facilitate irrigation and manipulation of the stones. The irrigation helps to maintain a clear visual field by displacing blood, stone fragments and debris.
Published
2025-03-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FFYAdaptor, Bulbs, Miscellaneous, For Endoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFYAdaptor, Bulbs, Miscellaneous, For EndoscopeGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16009900408313PackageGS110In Commercial Distribution
36009900408317PackageGS160In Commercial Distribution
06009900408316PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1600990040831316009900408313
3600990040831736009900408317
06009900408316060099004083166009900408316

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation tubing set, single-useA collection of flexible, noninvasive, single-lumen tubing and associated items intended to provide a conduit to deliver a sterile irrigation solution (e.g., saline) from its source (e.g., gravity feed bag, feed pump) to a surgical cannula (not included) during a surgical procedure (endoscopy, laparoscopy); it is not intended to navigate through an anatomical lumen. The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Fahrenheit104 Degrees Fahrenheit
Storage Environment Temperature0 Degrees Fahrenheit104 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+1 800.822.0314info@acemedicalco.com
+1 (513) 604-3430info@acemedicalco.com

Regulatory Flags#

DUNS number
850665825
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05906168942228Dual Action Pump Hand12025-03-17
05906168942211Dual Action Pump Foot12025-03-17
05906168942235Sealing Connector Y piece12025-03-17
05906168942242Sealing Connector I Piece 12025-03-17
05906168942259Sealing Connector T piece12025-03-17
16009900408313Peditrol12025-03-17
06009900408330Smart Bulb12025-03-17
06009900408439Mini Pillow12025-03-17
06009900639604Another Hand12025-03-17
59061689422282Dual Action Pump Hand12025-03-17

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Primary DI, Brand, Company table
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00724995356729CLEANASCOPE ADVANTAGECANTEL MEDICAL (ITALY) SRLFFY2026-05-26
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04897106957941andorate® 2-piece Cleaning Adapter + 3-piece Valve KitGA Health Company LimitedFFY2026-03-13
04897106957958andorate® 2-piece Cleaning Adapter + 4-piece Valve KitGA Health Company LimitedFFY2026-03-13
04897106958016andorate® 2-piece Cleaning Adapter + 3-piece Valve KitGA Health Company LimitedFFY2026-03-13
04897106958023andorate® 2-piece Cleaning Adapter + 4-piece Valve KitGA Health Company LimitedFFY2026-03-13
04897106957743andorate® Air Water Channel Cleaning AdapterGA Health Company LimitedFFY2025-11-21
04547410564112FUJIFILMFUJIFILM CORPORATIONFFY2025-10-24
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04897106957804Air/Water Channel Cleaning AdapterGA Health Company LimitedFFY2025-08-04
04897106957811Biopsy Port Cleaning AdapterGA Health Company LimitedFFY2025-08-04
04897106957828Air/Water Channel Cleaning AdapterGA Health Company LimitedFFY2025-08-04
04897106957798Air/Water Channel Cleaning AdapterGA Health Company LimitedFFY2025-08-04
14897106957801Air/Water Channel Cleaning AdapterGA Health Company LimitedFFY2025-08-04
14897106957818Biopsy Port Cleaning AdapterGA Health Company LimitedFFY2025-08-04
14897106957825Air/Water Channel Cleaning AdapterGA Health Company LimitedFFY2025-08-04
04897106957071Air Water Channel Cleaning AdapterGA Health Company LimitedFFY2025-07-31
14897106957078Air Water Channel Cleaning AdapterGA Health Company LimitedFFY2025-07-31
00850025860857CO2 Source Tubing Adapter Olympus UCRMicro-tech UsaFFY2025-05-12
00850025860864CO2 Source Tubing Adapter Fuji GW100Micro-tech UsaFFY2025-05-12
10850025860854CO2 Source Tubing Adapter Olympus UCRMicro-tech UsaFFY2025-05-12
10850025860861CO2 Source Tubing Adapter Fuji GW100Micro-tech UsaFFY2025-05-12
16009900408313PeditrolWISMED PL SP Z O OFFY2025-03-17
06009900408330Smart BulbWISMED PL SP Z O OFFY2025-03-17
06009900408439Mini PillowWISMED PL SP Z O OFFY2025-03-17
M78312011110Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FFY2025-01-10