FDA.reportPublic FDA data

GEMINI

Primary DI
00842071145002
Brand
GEMINI
Company
APPLIED MEDICAL TECHNOLOGY, INC.
Model
ESD221C-07
Catalog number
ESD221C-07, SD221C-07-101, SD221C-07-105
Device description
GEMINI Suture Passer with Magnet Technology (Curved Needle, Pouched)
Published
2024-10-04
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
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, 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
00842071145002PackageGS11In Commercial Distribution
00842071145019PackageGS15In Commercial Distribution
00842071144999PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842071145002008420711450028420711450020842071145002
00842071145019008420711450198420711450190842071145019
00842071144999008420711449998420711449990842071144999

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
038101861
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776435493MillenniumAvalign Technologies, Inc.GCJ2026-10-20
00190776435547MillenniumAvalign Technologies, Inc.GCJ2026-10-20
00190776435295MillenniumAvalign Technologies, Inc.GCJ2026-10-19
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