FDA.reportPublic FDA data

PEROUSE MEDICAL

Primary DI
03661234026883
Brand
PEROUSE MEDICAL
Company
PEROUSE MEDICAL
Model
03.804.413S
Catalog number
VPE0252NB1
Device description
INFLATION SYSTEM
Published
2025-10-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic manual surgical instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
13661234026880PackageGS115In Commercial Distribution
53661234026888PackageGS11In Commercial Distribution
03661234026883PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1366123402688013661234026880
5366123402688853661234026888
03661234026883036612340268833661234026883

GMDN Terms#

Term, Definition table
TermDefinition
Catheter/overtube balloon inflator, single-useA device designed to inflate and regulate the pressure of the balloon of a catheter, endoscopic overtube, or other invasive device (e.g., tamp, endomicroscopy probe), typically by injecting and aspirating fluid or air within the balloon, and to deflate the balloon during a medical procedure. It typically consists of a dedicated manual syringe/plunger or electronic mechanism for inflation/deflation, an analogue or digital gauge/screen for monitoring pressure, a locking mechanism, and a connecting tube. This is a single-use device.

Regulatory Flags#

DUNS number
267476323
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03661234027453PEROUSE MEDICAL2015SPIVPE2015SPI2026-01-22
03661234027460PEROUSE MEDICAL2015SPIMSTVPE2015SPIMST2026-01-22
03661234027477PEROUSE MEDICAL3015SPIVPE3015SPI2026-01-22
03661234027484PEROUSE MEDICAL3015SPIMSTVPE3015SPIMST2026-01-22
13661234027450PEROUSE MEDICAL2015SPIVPE2015SPI2026-01-22
13661234027467PEROUSE MEDICAL2015SPIMSTVPE2015SPIMST2026-01-22
13661234027474PEROUSE MEDICAL3015SPIVPE3015SPI2026-01-22
13661234027481PEROUSE MEDICAL3015SPIMSTVPE3015SPIMST2026-01-22
03661234017430INFLATION SYSTEM03.804.413S2017-04-12
03661234025213PEROUSE MEDICALE63101DPVPEE63101DP2024-11-11
33661234025214PEROUSE MEDICALE63101DPVPEE63101DP2024-11-11
03661234025206PEROUSE MEDICALE63101DNVPEE63101DN2024-04-09
33661234025207PEROUSE MEDICALE63101DNVPEE63101DN2024-04-09
03661234025190PEROUSE MEDICALE63101DMVPEE63101DM2024-03-26
03661234025237PEROUSE MEDICALE63101EAVPEE63101EA2024-03-26
43661234025198PEROUSE MEDICALE63101DMVPEE63101DM2024-03-26
43661234025235PEROUSE MEDICALE63101EAVPEE63101EA2024-03-26
03661234025183PEROUSE MEDICALE63101DLVPEE63101DL2024-03-20
03661234025220PEROUSE MEDICALE63101DRVPEE63101DR2024-03-20
03661234025244PEROUSE MEDICALE63101EBVPEE63101EB2024-03-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00824846013082Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-10-19
00850078396440SYNQ Single-Use Instrument System(1066)Eca Medical InstrumentsLXH2026-10-19
00889024715295Persona Extended V/V Guide Assembly (MFS)Zimmer, Inc.LXH2026-10-19
08809986489807LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-10-19
00810111228671Cut GuideTreace Medical Concepts, Inc.LXH2026-10-16
00810161900305EARP, TRIAL 22X35X12 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161900312EARP, TRIAL 22X35X14 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161900329EARP, TRIAL 22X35X12 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161900336EARP, TRIAL 22X35X14 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901418EARP TRIAL 22x40x10 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901425EARP TRIAL 22x40x12 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901432EARP TRIAL 22x40x14 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901449EARP TRIAL 22x40x12 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901456EARP TRIAL 22x40x14 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901463EARP TRIAL 22x45x10 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901470EARP TRIAL 22x45x12 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901487EARP TRIAL 22x45x14 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901494EARP TRIAL 22x45x12 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901500EARP TRIAL 22x45x14 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901692EARP TRIAL 22x50x10 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901708EARP TRIAL 22x50x12 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901715EARP TRIAL 22x50x14 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901722EARP TRIAL 22x50x12 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901739EARP TRIAL 22x50x14 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00840606197007MERCURYSPINAL ELEMENTS, INC.LXH2026-10-16
00840606197014MERCURYSPINAL ELEMENTS, INC.LXH2026-10-16
00840606197021MERCURYSPINAL ELEMENTS, INC.LXH2026-10-16
00840606197038MERCURYSPINAL ELEMENTS, INC.LXH2026-10-16
05055662922622Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDLXH2026-10-16
00810161900015EARP DISC SPACER INSERTERRETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15