FDA.reportPublic FDA data

PDB

Primary DI
10884521067943
Brand
PDB
Company
Covidien LP
Model
OMS-PDBS2
Device description
Kidney Shape Balloon
Published
2016-09-24
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEXPowered laser surgical instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K946002000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K946002000ORIGIN PREPERITONEAL DISSECTION BALLOON SYSTEM (PDBS)--EXTRAOrigin Medsystems, Inc.1995-01-05GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521067940PackageGS15In Commercial Distribution
10884521067943PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452106794020884521067940
1088452106794310884521067943

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic balloon dissectorA device designed to dissect connective tissue layers creating access to a desired surgical site during a laparoscopic procedure. It typically consists of a cannula, a distention balloon, an obturator, an inflation bulb, and a regulating valve(s). An appropriate endoscope is introduced into the cannula to monitor the dissection and/or the insertion process. Using the inflation bulb, the balloon is inflated to a recommended fill volume exerting pressure on the tissue layers. Once the space is dissected the balloon is deflated and the device replaced by other suitable devices (e.g., trocar/cannula) whilst the peritoneal space is insufflated under low pressure. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Fahrenheit130 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
058614483
Device count
1
Lot or batch
true
Expiration date on label
true

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