FDA.reportPublic FDA data

Smoke Aspiration Tip

Primary DI
M724SE100102
Brand
Smoke Aspiration Tip
Company
IMPLANTECH ASSOCIATES, INC.
Model
SE-100
Catalog number
SE-100
Device description
Smoke Aspiration Tip
Published
2021-07-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCXApparatus, Suction, Operating-Room, Wall Vacuum PoweredGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K931548000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K931548000INAMED DEVELOPMENT ASPIRATION TIPInamed Development Co.1994-01-10GCX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M724SE100102PackageHIBCC10In Commercial Distribution
M724SE100252PackageHIBCC25In Commercial Distribution
M724SE1001PrimaryHIBCC0

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

Contacts#

Phone, Email table
PhoneEmail
1-800-733-0833info@implantech.com

Regulatory Flags#

DUNS number
784664955
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M724MHTBL10WF401Silicone BlockSize: 14.5cm x 7.7cm x 1.0cmMHT-BL-1.0-WF-402026-08-25
M724MHTBL10WF501Silicone BlockSize: 14.5cm x 7.7cm x 1.0cmMHT-BL-1.0-WF-502026-08-25
M724MHTBL10WFVS50101Silicone BlockSize: 12.0cm x 7.0cm x 1.0cmMHT-BL-1.0-WFVS-50/102026-08-25
M724MHTBL10WM301Silicone BlockSize: 14.5cm x 7.7cm x 1.0cmMHT-BL-1.0-WM-302026-08-25
M724MHTBL10WS201Silicone BlockSize: 14.5cm x 7.7cm x 1.0cmMHT-BL-1.0-WS-202026-08-25
M724MHTBL12GM301Silicone BlockSize: 12.0cm x 7.0cm x 1.2cmMHT-BL-1.2-GM-302026-08-25
M724MCTBL10GF11Silicone Block, Grey, Firm 50 (EZ)Size: 14.5cm x 7.7cm x 1.0 cmMCT-BL-1.0-GF12026-04-16
M724MCTBL10GF21Silicone Block, Grey, Firm 50 (EZ)Size: 13.6cm x 5.8cm x 1.0cmMCT-BL-1.0-GF22026-04-16
M724MCTBL10OF1Silicone Block, Opaque, Firm 40 (EZ)Size: 13.6cm x 5.8cm x 1.0cmMCT-BL-1.0-OF2026-04-16
M724MCTBL13GM1Silicone Block, Grey, Medium 35 (EZ)Size: 15.0cm x 7.6cm x 1.3cmMCT-BL-1.3-GM2026-04-16
M724SMCOBL20FF1Silicone BlockSMCO-BL-2.0-FFSMCO-BL-2.0-FF2026-01-28
M724SMCOBL20OF1Silicone BlockSMCO-BL-2.0-OFSMCO-BL-2.0-OF2026-01-28
M724SMCOBL20OVS1Silicone BlockSMCO-BL-2.0-OVSSMCO-BL-2.0-OVS2026-01-28
M724SMCOBL20WF1Silicone BlockSMCO-BL-2.0-WFSMCO-BL-2.0-WF2026-01-28
M724SMCOBL20WVS1Silicone BlockSMCO-BL-2.0-WVSSMCO-BL-2.0-WVS2026-01-28
M724SLV6341Gelzone® Shoulder SleeveSLV634SLV6342023-06-22
M724NGBL20WMEZNS1Silicone Block 2.0Size: 14.9cm x 7.7cm x 2.0cmNG-BL-2.0-WM-EZ-NS2025-08-27
M724NGBL20CVFNS1Silicone Block 2.0Size: 14.9cm x 7.7cm x 2.0cmNG-BL-2.0-CVF-NS2025-08-27
M724NGBL20FFEZNS1Silicone Block 2.0Size: 14.9cm x 7.7cm x 2.0cmNG-BL-2.0-FF-EZ-NS2025-08-27
M724NGBL20FMEZNS1Silicone Block 2.0Size: 14.9cm x 7.7cm x 2.0cmNG-BL-2.0-FM-EZ-NS2025-08-27

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Primary DI, Brand, Company table
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10192253043389CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
10192253043396CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
10192253043402CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
10192253043419CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
08682952420093DeRoyalPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIGCX2025-11-06
00848530084011Oxygen AccessorySunset Healthcare Solutions, Inc.GCX2025-06-18
00848530099640Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCX2025-05-21
00848530103996Oxygen AccessorySunset Healthcare Solutions, Inc.GCX2025-05-14
00848530104009Oxygen Wrench and Washer KitSunset Healthcare Solutions, Inc.GCX2025-05-14
00848530105464Washer with Rubber Ring - AluminumSunset Healthcare Solutions, Inc.GCX2025-05-14
08682952418014PergoPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIGCX2025-05-13
00848530105747Oxygen AccessorySunset Healthcare Solutions, Inc.GCX2025-05-12
00848530105754Oxygen AccessorySunset Healthcare Solutions, Inc.GCX2025-05-12
00848530105723Oxygen AccessorySunset Healthcare Solutions, Inc.GCX2025-05-12
00848530105730Oxygen AccessorySunset Healthcare Solutions, Inc.GCX2025-05-12
08682952418144DeRoyalPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIGCX2025-05-08
08682952417437DeRoyalPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIGCX2025-05-07
08682952417451DeRoyalPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIGCX2025-05-07
08682952417482DeRoyalPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIGCX2025-05-07
10192253041736ArgyleCardinal Health 200, LLCGCX2025-03-24
10192253041743ArgyleCardinal Health 200, LLCGCX2025-03-24
10192253041750ArgyleCardinal Health 200, LLCGCX2025-03-24
10192253038965ArgyleCardinal Health 200, LLCGCX2025-02-28
10192253038972ArgyleCardinal Health 200, LLCGCX2025-02-28
10192253038989ArgyleCardinal Health 200, LLCGCX2025-02-28
10192253038996ArgyleCardinal Health 200, LLCGCX2025-02-28