FDA.report

SURGIPROS

Primary DI
00810143901191
Brand
SURGIPROS
Company
Surgipros, LLC
Model
27618SP
Device description
MANDRIN INSERTION CATHETER
Published
2023-09-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
EZBStylet For Catheter, Gastro-Urology

Product Code Classifications

CodeDeviceSpecialtyClass
EZBStylet For Catheter, Gastro-UrologyGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810143901191PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810143901191008101439011918101439011910810143901191

GMDN Terms

TermDefinition
Filiform urethral bougieAn extremely thin, wire-like, manual surgical instrument designed for traversing and exploring urethral strictures and/or dilating the urethra, introduced directly or through an appropriately-threaded urethral catheter. The tip of the device can be bent or contoured to shapes that will facilitate the progression of the device through the stricture; the tip may be bulbous (an olive tip). It is typically made of plastic material [e.g., polyvinyl chloride (PVC)] with a threaded metal section. It may be threaded at the proximal end to enable it to connect to a filiform follower (e.g., a larger diameter bougie). This is a single-use device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
4109600452info@surgipros.com

Regulatory Flags

DUNS number
058689193
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
00810143905779SURGIPROSWR412S2026-05-23
00810143907032SURGIPROSBC171SP2026-05-23
00810143907483SURGIPROSBC173SP2026-05-23
00810143907490SURGIPROS5005-44SP2026-05-23
00810143907537SURGIPROSBF113SP2026-05-23
00810212930374SURGIPROSBC181SP2026-05-23
00810212930480SURGIPROSBT041T2026-05-22
00810212930497SURGIPROSFB882SP2026-05-22
00810212930510SURGIPROS50-4681SP2026-05-22
00810212930534SURGIPROS50-4680SP2026-05-22
00810212930664SURGIPROSBC915SP2026-05-23
00810212930671SURGIPROSBC919SP2026-05-23
00810212930725SURGIPROSBC924SP2026-05-23
00810212931340SURGIPROSFB402T2026-05-22
00810212933054SURGIPROSEA016T2026-05-22
00810143905052SURGIPROS7803-65SP2024-09-18
00810143905113SURGIPROS9009-13SP2024-09-18
00810143905120SURGIPROS9009-14SP2024-09-18
00810143905137SURGIPROS3092SP2024-09-18
00810143905144SURGIPROS3099SP2024-09-18

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