FDA.reportPublic FDA data

GEMINI Suture Loop

Primary DI
00842071147297
Brand
GEMINI Suture Loop
Company
APPLIED MEDICAL TECHNOLOGY, INC.
Model
ES4-8000-01
Catalog number
ES4-8000-01, S4-8000-01
Device description
GEMINI Suture Loop with Magnet Technology (Pouched)
Published
2024-11-27
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
GATSuture, Nonabsorbable, Synthetic, Polyethylene
GCJLaparoscope, General & Plastic Surgery
KGCTube, Gastro-Enterostomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GATSuture, Nonabsorbable, Synthetic, PolyethyleneGeneral, Plastic Surgery2
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2
KGCTube, Gastro-EnterostomyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241111000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241111000AMT Suture PasserApplied Medical Technology, Inc.2024-07-05GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842071147303PackageGS11In Commercial Distribution
00842071147297PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842071147303008420711473038420711473030842071147303
00842071147297008420711472978420711472970842071147297

GMDN Terms#

Term, Definition table
TermDefinition
Suturing unit, single-useA non-powered, hand-held device intended to pass sutures or a needle/suture assembly through tissues/prosthetic materials to facilitate suturing during an endoscopic and/or open surgical procedure; it may also knot, cut and/or tighten the sutures/ligature loop during or after placement. It typically consists of a shaft with hooks, catches, clasps, or forceps-like jaws at the distal end, and a proximal handle with controls. It typically has a pointed/cutting component to create a suture tunnel, and is loaded with the sutures or the suture is inserted through the shaft. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
038101861
Device count
1
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
00842071146474MINI Balloon Button5-16275-16272026-10-22
00842071146481MINI Balloon Button5-1627-I5-1627-I2026-10-22
00842071146498MINI Balloon Button5-16305-16302026-10-22
00842071146504MINI Balloon Button5-1630-I5-1630-I2026-10-22
00842071146535MINI Balloon Button5-16405-16402026-10-22
00842071146542MINI Balloon Button5-1640-I5-1640-I2026-10-22
00842071147075MINI Balloon Button5-20445-20442026-10-22
00842071147082MINI Balloon Button5-2044-I5-2044-I2026-10-22
00842071147259MINI Balloon Button5-24405-24402026-10-22
00842071147266MINI Balloon Button5-2440-I5-2440-I2026-10-22
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

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Primary DI, Brand, Company table
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00190776434922MillenniumAvalign Technologies, Inc.GCJ2026-10-14
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B382SD56300680Surgical DirectSurgical Direct, Inc.GCJ2026-10-13
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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
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