FDA.reportPublic FDA data

Remora Smoke and Fluid Evacuation System

Primary DI
00842071139353
Brand
Remora Smoke and Fluid Evacuation System
Company
APPLIED MEDICAL TECHNOLOGY, INC.
Model
EST9100
Catalog number
EST9100, ST9100
Device description
Remora Smoke and Fluid Evacuation System Micro (Sterile, Pouched), MDR
Published
2024-11-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K971758000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K971758000CAUTERIZATION SMOKE EVACUATORApplied Medical Technologies1997-07-21GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842071139377PackageGS110In Commercial Distribution
00842071139353PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842071139377008420711393778420711393770842071139377
00842071139353008420711393538420711393530842071139353

GMDN Terms#

Term, Definition table
TermDefinition
Surgical plume evacuation systemA mains electricity (AC-powered) assembly of devices intended to capture smoke generated during open surgical procedures involving tissue ablation (e.g., laser surgery, electrocautery, electrosurgical diathermy device). It captures the plume (smoke composed of carbonized cell fragments, water vapour, and hydrocarbons from vaporized tissue) near its origin before it becomes dispersed and causes surgical staff respiratory exposure. It consists of a capture tube or wand and four elements to evacuate smoke: user interface, filters, suction source, and exhaust. The system may be mobile (on wheels) and used during closed surgical procedures (e.g., endoscopy, laparoscopy) to clear the view. See also: Gas/fume evacuation system; Anaesthetic gas scavenging unit; Suction system filter, plume particulate; Orthopaedic cement fume evacuator; Surgical plume evacuation system tube

Contacts#

Phone, Email table
PhoneEmail
(440) 717-4000cs@appliedmedical.net

Regulatory Flags#

DUNS number
038101861
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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Primary DI, Brand, Model table
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00842071147204MINI Balloon Button5-2427-I5-2427-I2026-05-07
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00842071146276MINI Balloon Button5-14555-14552026-04-09
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00842071151140RHAPSOESD110-C-07ESD110-C-07, SD110-C-07-101, SD110-C-07-1052026-03-25
00842071153021AMT MiniONE Extension SetE8-1255-ISOSAFE8-1255-ISOSAF, 8-1255-ISOSAF2026-03-23
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00842071150952AMT MiniSPC Drainage SetES1-1221ES1-1221, S1-12212026-03-18
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