FDA.reportPublic FDA data

CooperSurgical, Inc.

Primary DI
60888937003248
Brand
CooperSurgical, Inc.
Company
Coopersurgical, Inc.
Model
47-9005
Device description
Adult Esophageal Balloon Catheter Set; PTFE Coated Stylet; 5 French
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GBACatheter, Balloon Type

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBACatheter, Balloon TypeGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888937003240PackageGS15In Commercial Distribution
30888937003247PackageGS120In Commercial Distribution
60888937003248PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088893700324020888937003240
3088893700324730888937003247
6088893700324860888937003248

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
801895244
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888937033687ONETRACC1001502026-07-10
00888937033694ONETRACC1001652026-07-10
00888937033700ONETRACC1001702026-07-10
00888937033717ONETRACC1001802026-07-10
00888937033724ONETRACC1001902026-07-10
00888937033731ONETRAC LXC1002102026-07-10
00888937033748ONETRAC LXC1002202026-07-10
00888937033755ONETRAC LXC1002302026-07-10
00888937033762ONETRAC LXC1002402026-07-10
00888937033779ONETRAC LXC1002502026-07-10
00888937033786ONETRAC™ LXSC1002602026-07-10
00888937033793ONETRAC™ LXSC1002702026-07-10
00888937033809ONETRAC™ LXSC1002802026-07-10
00888937033816ONETRAC™ LXSC1002902026-07-10
00888937033823ONETRAC™ LXSC1102002026-07-10
00888937033830ONETRAC™ LXSC1102102026-07-10
00888937033847ONETRAC™ LXSC1102202026-07-10
00888937033854ONETRAC™ LXSC1103102026-07-10
00888937033861ONETRAC™ LXSC1103202026-07-10
00888937033663ONETRAC™C1001102026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860014541704EnvisionSPINAL STABILIZATION TECHNOLOGIES LIMITEDGBA2026-04-30
00860014541711EnvisionSPINAL STABILIZATION TECHNOLOGIES LIMITEDGBA2026-04-30
06979032640031GOBENHUZHOU JUNDA INDUSTRY CO., LTD.GBA2025-08-26
M7403150006VerifySPINEOLOGY INC.GBA2023-06-26
00887482173718Symmetry Surgical®ASPEN SURGICAL PRODUCTS, INC.GBA2022-09-21
00678467004963 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
00678467005007 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
00678467005847 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
00678467005915 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
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