FDA.reportPublic FDA data

"Retrieval Pouch-Rip Stop-W/Pull Strap - 7"" x 10"""

Primary DI
B354OSRP710W0
Brand
"Retrieval Pouch-Rip Stop-W/Pull Strap - 7"" x 10"""
Company
ORANGE SURGICAL INSTRUMENTS, LLC
Model
OSRP710W
Device description
"Retrieval Pouch-Rip Stop-W/Pull Strap - 7"" x 10"""
Published
2016-11-15
Public version status
Update
Distribution status
Not 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
DWSInstruments, Surgical, Cardiovascular
GCJLaparoscope, General & Plastic Surgery
GEIElectrosurgical, Cutting & Coagulation & Accessories
HIFInsufflator, Laparoscopic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2
HIFInsufflator, LaparoscopicObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B354OSRP710W10PackageHIBCC10Not in Commercial Distribution
B354OSRP710W0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Tissue extraction bagAn impervious, flexible, sterile container intended to be used during minimally-invasive, typically keyhole, surgical techniques (e.g., laparoscopic) to extract dissected patient body tissue. The device is inserted into the body through a large bore cannula port, and the tissue to be extracted is placed in the bag with trans-cannula instruments and evacuated through the cannula. The device typically includes an x-ray detectable thread. This device may be used for surgical interventions such as an appendectomy, colonectomy, lymphadenectomy, or gallbladder removal. This is a single-use device.

Regulatory Flags#

DUNS number
047063695
Device count
1
Lot or batch
true
Expiration date on label
true

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