FDA.reportPublic FDA data

Opus Colibri 0.7mm Single-use Tip (X1)

Primary DI
17290110122178
Brand
Opus Colibri 0.7mm Single-use Tip (X1)
Company
ALMA LASERS LTD.
Model
1
Catalog number
AACL03052001
Device description
Opus Colibri 0.7mm Single-use Tip one ubit
Published
2021-11-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories
IMIUltrasonic Diathermy For Use In Applying Therapeutic Deep Heat
ISAMassager, Therapeutic, Electric
NUVMassager, Vacuum, Light Induced Heating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2
IMIUltrasonic Diathermy For Use In Applying Therapeutic Deep HeatPhysical Medicine2
ISAMassager, Therapeutic, ElectricPhysical Medicine1
NUVMassager, Vacuum, Light Induced HeatingGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K101147000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101147000MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEMAlma Lasers, Inc.2011-01-21NUV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290110122178PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1729011012217817290110122178

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
532283264
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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