FDA.reportPublic FDA data

Medline

Primary DI
10080196286812
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
MDG7100030
Catalog number
MDG7100030
Device description
LAPAROSCOPE,TELESCOPE,10MM,30DEG,45CM
Published
2022-01-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
K060233000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060233000TROKAMED GMBH ENDOSCOPES AND ACCESSORIESTrokamed GmbH2006-07-19GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10080196286812PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1008019628681210080196286812

GMDN Terms#

Term, Definition table
TermDefinition
Rigid endoscope telescopeAn optical device designed to provide the illumination and image transmission capabilities of a rigid endoscope. It typically includes a set of lenses (e.g., thin and rod-shaped lenses) and/or a fibreoptic bunch, and is introduced though the sheath of the endoscope (e.g., a rigid cystoscope or resectoscope). The endoscopic telescope is connected proximally to a light source, and the returning image is directly observed or scanned with a video camera. Dedicated types are available for direct, lateral, and oblique views. It is used for examination of body cavities following natural tracts (e.g., urinary, gastrointestinal) or surgical cavities (e.g., laparoscopic). This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00197344205281CURADCUR47451RBCUR47451RB2026-10-29
00884389108362CURADCUR4025RCUR4025R2026-10-29
00884389108393CURADCUR4135RCUR4135R2026-10-29
00888277187088CURADCUR4125RCUR4125R2026-10-29
10197344148608MEDLINERTDCIVDHGRTDCIVDHG2026-10-29
10197344148615MEDLINERTDCIVDHNRTDCIVDHN2026-10-29
10197344148622MEDLINERTDCIVDHPRTDCIVDHP2026-10-29
10197344148639MEDLINERTDCIVDHRRTDCIVDHR2026-10-29
10197344148646MEDLINERTDCIVDHYRTDCIVDHY2026-10-29
10197344148653MEDLINERTDCIVDHZRTDCIVDHZ2026-10-29
10197344219278MEDLINEDYNDSCL3000RDYNDSCL3000R2026-10-29
10197344223862MEDLINEDYSNR24OVCOLDDYSNR24OVCOLD2026-10-29
10653160395690MEDLINEDYNDC3636DYNDC36362026-10-29
10653160395768MEDLINECVI5130BCVI5130B2026-10-29
10653160395874MEDLINEEBSI1161BEBSI1161B2026-10-29
10653160395935MEDLINEDYNDH2410DYNDH24102026-10-29
10653160395966MEDLINEEBSI1729BEBSI1729B2026-10-29
10653160396017MEDLINEEBSI1427BEBSI1427B2026-10-29
10653160396024MEDLINEDYNDC3648DYNDC36482026-10-29
10653160396031MEDLINEEBSI1840AEBSI1840A2026-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD13517450Surgical DirectSurgical Direct, Inc.GCJ2026-10-28
B382SD13518130Surgical DirectSurgical Direct, Inc.GCJ2026-10-28
B382SD15908130Surgical DirectSurgical Direct, Inc.GCJ2026-10-28
B382SD77505940Surgical DirectSurgical Direct, Inc.GCJ2026-10-28
00190776436827MillenniumAvalign Technologies, Inc.GCJ2026-10-22
B382SD772553050Surgical DirectSurgical Direct, Inc.GCJ2026-10-22
00190776435677MillenniumAvalign Technologies, Inc.GCJ2026-10-21
00190776435684MillenniumAvalign Technologies, Inc.GCJ2026-10-21
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