FDA.report

Carriere InfiNiTi Loops

Primary DI
10190707105690
Brand
Carriere InfiNiTi Loops
Company
ORTHO ORGANIZERS, INC.
Model
102-04SS
Device description
Carriere® InfiNiTi Loops™ Size Selector 4-Loop (10)
Published
2024-03-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
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
00190707105693PrimaryGS10
10190707105690Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190707105693001907071056931907071056930190707105693
1019070710569010190707105690

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
062165188
Device count
10
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00190707096816Reveal® Aligners139-61102022-01-06
00190707096823Reveal® Aligners139-61112022-01-06

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