FDA.reportPublic FDA data

Abeon Guyuron E.A.D.

Primary DI
00842071109882
Brand
Abeon Guyuron E.A.D.
Company
APPLIED MEDICAL TECHNOLOGY, INC.
Model
ST8001
Device description
Endoscopic Access Device (Box 10)
Published
2016-09-23
Public version status
Update
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
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K960232000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K960232000ENDOSCOPIC ACCESS DEVICEApplied Medical Technologies1996-03-21GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842071109882PrimaryGS10
00842071109325Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842071109882008420711098828420711098820842071109882
00842071109325008420711093258420711093250842071109325

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope working-channel sealA sterile device intended to be fitted over the working channel access port of an endoscope to minimize leakage of liquids and gases through the working channel, while permitting entry of endoscopic devices. It is typically a small plastic Luer attachment with an intraluminal seal. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
038101861
Device count
10
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842071146337MINI Balloon Button5-16105-16102026-10-20
00842071146344MINI Balloon Button5-1610-I5-1610-I2026-10-20
00842071146375MINI Balloon Button5-16155-16152026-10-20
00842071146382MINI Balloon Button5-1615-I5-1615-I2026-10-20
00842071146795MINI Balloon Button5-18445-18442026-10-20
00842071146801MINI Balloon Button5-1844-I5-1844-I2026-10-20
00842071147136MINI Balloon Button5-24205-24202026-10-20
00842071147143MINI Balloon Button5-2420-I5-2420-I2026-10-20
00842071147150MINI Balloon Button5-24235-24232026-10-20
00842071147167MINI Balloon Button5-2423-I5-2423-I2026-10-20
00842071147174MINI Balloon Button5-24255-24252026-10-20
00842071147181MINI Balloon Button5-2425-I5-2425-I2026-10-20
00842071147211MINI Balloon Button5-24305-24302026-10-20
00842071147228MINI Balloon Button5-2430-I5-2430-I2026-10-20
00842071147273MINI Balloon Button5-24445-24442026-10-20
00842071147280MINI Balloon Button5-2444-I5-2444-I2026-10-20
00842071146634MINI Balloon Button5-18175-18172026-10-19
00842071146641MINI Balloon Button5-1817-I5-1817-I2026-10-19
00842071146672MINI Balloon Button5-18235-18232026-10-19
00842071146689MINI Balloon Button5-1823-I5-1823-I2026-10-19

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00190776435455MillenniumAvalign Technologies, Inc.GCJ2026-10-19
B354OSCVORTH80Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH81Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH82Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH83Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH84Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH85Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH89Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
04548736175013OLYMPUSSONY CORPORATIONGCJ2026-10-15
04548736175068OLYMPUSSONY CORPORATIONGCJ2026-10-15
04548736175112OLYMPUSSONY CORPORATIONGCJ2026-10-15
00190776434922MillenniumAvalign Technologies, Inc.GCJ2026-10-14
00190776434823MillenniumAvalign Technologies, Inc.GCJ2026-10-13
00190776434854MillenniumAvalign Technologies, Inc.GCJ2026-10-13
B382SD56300680Surgical DirectSurgical Direct, Inc.GCJ2026-10-13
B382SD563006820Surgical DirectSurgical Direct, Inc.GCJ2026-10-13
00190776434250MillenniumAvalign Technologies, Inc.GCJ2026-10-09
00848657078481AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GCJ2026-10-08
00848657078498AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GCJ2026-10-08
00190776433697MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433703MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433710MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433727MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433338MillenniumAvalign Technologies, Inc.GCJ2026-10-05
00190776433345MillenniumAvalign Technologies, Inc.GCJ2026-10-05
00190776433031MillenniumAvalign Technologies, Inc.GCJ2026-10-01
00190776433079MillenniumAvalign Technologies, Inc.GCJ2026-10-01