FDA.report

Durma+ DynaRule Disposable Paper Rulers

Primary DI
00810180843331
Company
Dynarex Corporation
Model
3006
Published
2026-03-24
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

Regulatory Flags

DUNS number
008124539
Device count
10
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
true
Sterilization required before use
false

Identifiers

IdentifierTypeAgencyPackage quantityStatus
00840117349834PackageGS160In Commercial Distribution
00840117349827PrimaryGS10
00810180843331Unit of UseGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
00840117349834PackageGS160Shipper 00840117349827In Commercial Distribution
00840117349827PrimaryGS10
00810180843331Unit of UseGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
FTYTape, Measuring, Rulers And Calipers1General, Plastic Surgery878.4800NEligible

Premarket Submissions

No records found.

Premarket Details

No records found.

GMDN Terms

TermDefinition
Tape measure, single-useA flexible, manual, non-electronic device intended to be used in a clinical setting to establish an accurate measurement of length greater than a standard ruler (e.g., anatomical measurements of newborn babies). It is typically made of silk-coated paper and marked in units of length (i.e., inches and/or millimetres); some types may have a writing field to record patient data (e.g., name, sex, date of birth). This is a single-use device.

Device Sizes

No records found.

Storage And Handling

No records found.

Sterilization Methods

Method

Contacts

No records found.

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