FDA.reportPublic FDA data

Endoplus

Primary DI
00817401029161
Brand
Endoplus
Company
Endoplus
Model
E348RR-45
Device description
5mm Ripple Claw Forcep, Ratcheting Handle, With Rotation, Bariatric Length
Published
2026-06-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HETLaparoscope, Gynecologic (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HETLaparoscope, Gynecologic (And Accessories)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K925079000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K925079000LAPAROSCOPIC INST. (SCISSORS,FORCEPS,NEEDLEHOLDER)Endo Technic Corp.1994-08-24HET

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817401029161PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817401029161008174010291618174010291610817401029161

GMDN Terms#

Term, Definition table
TermDefinition
Rigid endoscopic tissue manipulation forceps, reusableA rigid, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope and/or an endoscopic port (e.g., laparoscopic port) primarily for grasping and manipulating tissues during endoscopic surgery. It has proximal controls (e.g., scissors-like handles), a rigid long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
794679167
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817401029147EndoplusE332RR-452026-05-13
00817401029154EndoplusE382RR-452026-05-13
00817401029130EndoplusE322S2026-02-06
00817401029123EndoplusE404RR2026-01-16
00817401029116EndoplusE404RR-452025-12-19
00817401029109EndoplusE356SL2025-04-10
00817401029093EndoplusE308RR-452025-03-14
00817401029079EndoplusE339SLR2024-12-13
00817401029086EndoplusE302R2024-12-13
00817401029062EndoplusE363RR-452024-11-21
00817401029048EndoplusE382MR2024-08-30
00817401029055EndoplusE382RR2024-08-30
00817401028614EndoplusE300DVR2024-04-30
00817401028621EndoplusE300DVR-452024-04-30
00817401028638EndoplusE307DVR2024-04-30
00817401028645EndoplusE307DVR-452024-04-30
00817401028652EndoplusE313DVR2024-04-30
00817401028669EndoplusE313DVR-452024-04-30
00817401028676EndoplusE317DVR2024-04-30
00817401028683EndoplusE317DVR-452024-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506091452ELMED INCORPORATEDELMED INCORPORATEDHET2026-06-05
00198506091469ELMED INCORPORATEDELMED INCORPORATEDHET2026-06-05
10653405044703CORE DYNAMICSConmed CorporationHET2026-03-23
10887482155261Symmetry Secto®ASPEN SURGICAL PRODUCTS, INC.HET2024-09-09
10887482155285Symmetry Secto®ASPEN SURGICAL PRODUCTS, INC.HET2024-09-09
10887482155308Symmetry Secto®ASPEN SURGICAL PRODUCTS, INC.HET2024-09-09
10887482155322Symmetry Secto®ASPEN SURGICAL PRODUCTS, INC.HET2024-09-09
10381780538608Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538622Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538646Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538660Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538677Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538691Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538707Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538714Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538721Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538776MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538783MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538790Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538806Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538813Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538837MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538844MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538851Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538899Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538905Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538936Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538943Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538950Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780539001Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29