FDA.report

DynaRule Bullseye Measuring Guide

Primary DI
00616784300733
Brand
DynaRule Bullseye Measuring Guide
Company
DYNAREX CORPORATION
Model
3007
Device description
DynaRule Bullseye Measuring Guide
Published
2021-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
FTYTape, Measuring, Rulers And Calipers

Product Code Classifications

CodeDeviceSpecialtyClass
FTYTape, Measuring, Rulers And CalipersGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784300733PackageGS15In Commercial Distribution
00616784300726PrimaryGS10
00616784300719Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784300733006167843007336167843007330616784300733
00616784300726006167843007266167843007260616784300726
00616784300719006167843007196167843007190616784300719

GMDN Terms

TermDefinition
Medical ruler, single-useA small straight-edged strip intended to be used to measure the length of internal or external anatomy, devices or instruments in a clinical setting. It is marked in units of length (i.e., inches, millimetres and/or centimetres), and may be bendable to fit on the measured surfaces. It is not dedicated to wound measurements. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008124539
Device count
250
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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