FDA.reportPublic FDA data

RetroPerc

Primary DI
00860000917506
Brand
RetroPerc
Company
RETROPERC INC.
Model
RP91-01
Catalog number
RP91-01
Device description
Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set
Published
2025-01-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LJECatheter, Nephrostomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJECatheter, NephrostomyUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860000917506PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860000917506008600009175068600009175060860000917506

GMDN Terms#

Term, Definition table
TermDefinition
Nephrostomy introduction sheathA flexible or rigid tube intended to be inserted percutaneously into the renal pelvis to gain access to the upper urinary tract to maintain a nephrostomy tract for the introduction of other instruments (e.g., endoscope, guidewire, catheter); it is not a nephrostomy catheter. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
2489757372info@retroperc.com

Regulatory Flags#

DUNS number
112165284
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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06973356554777TriousShenzhen Trious Medical Technology Co., Ltd.LJE2026-03-27
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05701780270953KolibriColoplast A/SLJE2023-01-20
05701780270984KolibriColoplast A/SLJE2023-01-20
05701780271059KolibriColoplast A/SLJE2023-01-20
05701780271080KolibriColoplast A/SLJE2023-01-20
05701780271110KolibriColoplast A/SLJE2023-01-20
05701780271141KolibriColoplast A/SLJE2023-01-20
05701780271172KolibriColoplast A/SLJE2023-01-20
05701780271202KolibriColoplast A/SLJE2023-01-20
05701780271233KolibriColoplast A/SLJE2023-01-20
05701780271264KolibriColoplast A/SLJE2023-01-20
05701780271295KolibriColoplast A/SLJE2023-01-20
05701780271325KolibriColoplast A/SLJE2023-01-20
05701780271356KolibriColoplast A/SLJE2023-01-20
05701780271394KolibriColoplast A/SLJE2023-01-20
05701780271424KolibriColoplast A/SLJE2023-01-20
05701780271455KolibriColoplast A/SLJE2023-01-20
05701780271486KolibriColoplast A/SLJE2023-01-20
05701780271530KolibriColoplast A/SLJE2023-01-20
05701780271561KolibriColoplast A/SLJE2023-01-20
05701780271608KolibriColoplast A/SLJE2023-01-20
05701780271639KolibriColoplast A/SLJE2023-01-20
05701780271660KolibriColoplast A/SLJE2023-01-20
05701780271691KolibriColoplast A/SLJE2023-01-20
05701780271721KolibriColoplast A/SLJE2023-01-20