FDA.reportPublic FDA data

Speculum Tubing

Primary DI
00817688021407
Brand
Speculum Tubing
Company
I.C. MEDICAL, INC.
Model
ICM-000-0365
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K930098000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K930098000SPECULUM SMOKE EVACUATOR TUBINGI.C Medical, Inc.1993-07-28GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817688021407PackageGS19In Commercial Distribution
00817688021391PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817688021407008176880214078176880214070817688021407
00817688021391008176880213918176880213910817688021391

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
1
DM exempt
false
Premarket exempt
false
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
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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