FDA.reportPublic FDA data

Smoke Tubing

Primary DI
00817688021810
Brand
Smoke Tubing
Company
I.C. MEDICAL, INC.
Model
ICM-000-0274
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
FYDApparatus, Exhaust, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FYDApparatus, Exhaust, SurgicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K932230000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K932230000CRYSTAL VISION AND ACCESSORIESI.C Medical, Inc.1994-02-18FYD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817688021810PrimaryGS10
00817688021568Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817688021810008176880218108176880218100817688021810
00817688021568008176880215688176880215680817688021568

GMDN Terms#

Term, Definition table
TermDefinition
Surgical plume evacuation system tubeA sterile, long, hollow cylinder which, as part of a surgical smoke evacuation system, is used to capture and conduct to exhaust the plume generated during open surgical procedures in which there is tissue ablation (e.g., laser surgery, electrocautery, electrosurgical diathermy device). This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
616182895
Device count
5
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817688022992STERISSSEFIL01SSEFIL012021-10-19
00817688023043STERISSSEPEN02SSEPEN022021-10-19
00817688023142STERISSSEPEN07SSEPEN072021-10-19
00817688023289STERISSSEPET02SSEPET022021-10-19
00817688023364STERISSSEPET06SSEPET062021-10-19
00817688023531STERISSSESHR01SSESHR012021-10-19
00817688023630STERISSSETUB01SSETUB012021-10-19
00817688023708STERISSSEPEN14SSEPEN142022-05-11
00817688022978STERISSSECAPPLSSSECAPPLS2021-10-19
00817688022985STERISSSECAPREGSSECAPREG2021-10-19
00817688023012STERISSSEFIL02SSEFIL022021-10-19
00817688023500STERISSSESEN01SSESEN012021-10-19
00817688023524STERISSSESEN03SSESEN032021-10-19
00817688023029STERISSSEPEN01SSEPEN012021-10-19
00817688023074STERISSSEPEN03SSEPEN032021-10-19
00817688023081STERISSSEPEN04SSEPEN042021-10-19
00817688023104STERISSSEPEN05SSEPEN052021-10-19
00817688023128STERISSSEPEN06SSEPEN062021-10-19
00817688023173STERISSSEPEN08SSEPEN082021-10-19
00817688023197STERISSSEPEN09SSEPEN092021-10-19

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