Rigid 3-Prong Grasper For Retrieval of Large Stone Fragments U-Type H

Primary DI
00821925007956
Brand
Rigid 3-Prong Grasper For Retrieval of Large Stone Fragments U-Type H
Company
Gyrus Acmi, Inc.
Model
RPG-437
Device description
RPG-437 Forceps, Rigid 3-Prong Graspin g
Published
2016-10-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
FGODISLODGER, STONE, FLEXIBLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGODislodger, Stone, FlexibleGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821925007956PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925007956008219250079568219250079560821925007956

GMDN Terms#

Term, Definition table
TermDefinition
Rigid endoscopic stone-retrieval forceps, reusableA rigid manual device intended to be inserted through the working channel of a compatible endoscope to grasp and remove stones (e.g., calculi from the urinary tract) or foreign bodies during an endoscopic procedure. It is typically a very long instrument with one sliding and one stationary rod, or a sheath, whose distal ends are equipped with thin grasping claws in which the stone is seized and held for extraction. The claws are typically operated by scissors-like ring handles at the proximal end of the instrument. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
007198742
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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00821925002166USA Elite SystemEROS-CF252024-07-25
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00821925008083Bovie5686042024-07-25
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00821925009523IRRI-FLO I 59200002024-07-25
00821925011427DIEGO703390502024-07-25

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