FDA.reportPublic FDA data

Forceps

Primary DI
00846338005719
Brand
Forceps
Company
ELLIQUENCE, LLC
Model
15-1631
Device description
Cup Forceps, OD: 3.0mm, WL:158.0mm
Published
2026-06-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HTXRongeur

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTXRongeurOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846338005719PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846338005719008463380057198463380057190846338005719

GMDN Terms#

Term, Definition table
TermDefinition
Rigid endoscopic biopsy forceps, reusableA rigid, manual, non-electrosurgical instrument intended to obtain tissue specimens during endoscopic procedures (e.g., laparoscopy, thoracoscopy, spinoscopy, arthroscopy). It is typically constructed as a long instrument with one sliding and one stationary rod whose distal ends are equipped with scissors-like cups with cutting edge rims, which are operated by a control handle at the proximal end of the instrument. It is introduced into the body through an artificial orifice of the body or the working channel of the endoscope. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
019872358
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
00846338001209IEC BiPolar Cable, DisposableIEC-DJX/12026-06-03
00846338001230Bipolar CableBCD-EU/12026-06-03
00846338001247Bipolar Cable - 2 Flat ProngsBCD-FP/12026-06-03
00846338001537Bipolar Cable - 2 Flat ProngsIEC-JX/B2026-06-03
00846338001582IEC Power Cord 110vIEC-PC1102026-06-03
00846338001605IEC Power Cord 220v ANZ PlugIEC-PCANZ2026-06-03
00846338001612IEC Power Cord 220v EuropeIEC-PCEU2026-06-03
00846338001629IEC Power Cord U.K. 220vIEC-PCUK2026-06-03
00846338005436Working Port15-29062026-06-02
00846338005689Curette15-25372026-06-02
00846338005696Curette15-25382026-06-02
00846338005702Curette15-25392026-06-02
00846338005726Forceps15-16322026-06-02
00846338005757Forceps15-16432026-06-02
00846338005764Forceps15-16442026-06-02
00846338005771Forceps15-16512026-06-02
00846338005788Forceps15-16522026-06-02
00846338005801Kerrison15-19252026-06-02
00846338005818Kerrison15-19262026-06-02
00846338005825Kerrison15-19272026-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD914341100Surgical DirectSurgical Direct, Inc.HTX2026-07-13
B382SD9227021010Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD92270212C0Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD922707140Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD922707150Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD922707160Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD922707170Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD922707180Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD922707190Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD922734060Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD922734070Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD922734080Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD922738100Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD9227381000Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD9227381010Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD9227381020Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD922738990Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD92274510120Surgical DirectSurgical Direct, Inc.HTX2026-07-10
B382SD9227771090Surgical DirectSurgical Direct, Inc.HTX2026-07-10
00810168190396NAPACIFIC INSTRUMENTS, INC.HTX2026-06-26
00198506091216ELMED INCORPORATEDELMED INCORPORATEDHTX2026-06-03
00846338005726ForcepsELLIQUENCE, LLCHTX2026-06-02
00846338005757ForcepsELLIQUENCE, LLCHTX2026-06-02
00846338005764ForcepsELLIQUENCE, LLCHTX2026-06-02
00846338005771ForcepsELLIQUENCE, LLCHTX2026-06-02
00846338005788ForcepsELLIQUENCE, LLCHTX2026-06-02
00810189451490Surgical DesignSurgical Design, Inc.HTX2026-05-29
09348811172174INKAThe Trustee for KAISER FAMILY TRUSTHTX2025-11-21
G586NS5235002SPFB10Novo SurgicalNOVO SURGICAL, INC.HTX2025-02-06
B382SD9238331020Surgical DirectSurgical Direct, Inc.HTX2024-06-25