FDA.reportPublic FDA data

COMPRESSION PADDLE

Primary DI
00843696114312
Brand
COMPRESSION PADDLE
Company
Flow X Ray Corporation
Model
14107
Device description
Designed for applying compression during G.I. series, our Wolf Compression Paddle is ideal for displacing barium, deflecting an intestinal loop, or applying compression for similar reasons.The Paddle features a rubber compression bladder, easily inflated by means of a built-in baumanometer bulb. A metal circle in the bladder ring fluoroscopically indicates the area under compression.
Published
2022-12-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HWNInstrument, Compression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWNInstrument, CompressionOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00843696114312PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843696114312008436961143128436961143120843696114312

GMDN Terms#

Term, Definition table
TermDefinition
Mammographic x-ray system compression paddleA mechanically, electronically or software-controlled component of a mammographic x-ray system used to flatten and stabilize the breast during mammography studies or mammography system-guided biopsy procedures. This device typically consists of paddles or plates, associated mounts, and controls.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
010016319
Device count
1
DM exempt
true
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00081204503900DV-58 ADULT ECONO PAK182042023-08-09
00812045030115DX-58 ADULT PAPER PAK180012023-08-09
00812045030634DX-42 BITE CHEX180602023-08-09
00812045030832DV-57 ADULT TWIN VALUE PAK18201E2023-08-09
00812045030849DV-53 CHILD TWIN PEDO PAK18236E2023-08-09
00812045030856DSS-54 D CHILD SINGLE FILM BUTTERFLY PACKET19235E2023-08-09
00812045030863DSS-57 D ADULT SINGLE FILM BUTTERFLY PACKET19601E2023-08-09
00812045030870" DUPLICATING FILM, 14 X 17"""311762023-08-09
00812045030887DV-58 ADULT VALUE PAK182002023-08-09
00812045030894DV-57 ADULT TWIN VALUE PAK182012023-08-09
00812045030917DV-54 CHILD ECONO PAK182062023-08-09
00812045030924FV-58 ADULT ECONO PAK182152023-08-09
00812045030931DV-54 CHILD PEDO PAK182352023-08-09
00812045030948DV-53 CHILD TWIN PEDO PAK182362023-08-09
00812045030955FV-58 ADULT VALUE PAK183102023-08-09
00812045030962FV-57 ADULT TWIN VALUE PAK184102023-08-09
00812045030979DV-58 ADULT FRESH PAK186002023-08-09
00812045030986DV-57 ADULT TWIN FRESH PAK186012023-08-09
00812045030993FV-58 ADULT FRESH PAK186202023-08-09
00812045031006FV-57 ADULT TWIN FRESH PAK186212023-08-09

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