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
00810130207435MSIModern Surgical Instruments LLCLXH2026-07-14
00840606188128Ventana ASPINAL ELEMENTS, INC.LXH2026-07-13
08809695601903AnyPlus®GS Medical Co., Ltd.LXH2026-04-21
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08800322743195PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743201PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743218PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18