FDA.reportPublic FDA data

Key Surgical Foreign Body Retrievers

Primary DI
00849771039969
Brand
Key Surgical Foreign Body Retrievers
Company
KEY SURGICAL, INC.
Model
EN10137A
Device description
Grasping Forceps, 5-Pod Type, 2.3mm Diam, 2300mm L
Published
2020-08-05
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDJClamp, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDJClamp, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00849771041085PackageGS110Not in Commercial Distribution
00849771039969PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849771041085008497710410858497710410850849771041085
00849771039969008497710399698497710399690849771039969

GMDN Terms#

Term, Definition table
TermDefinition
Flexible endoscopic tissue manipulation forceps, single-useA flexible, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope to grasp tissue (typically atraumatically), or additionally foreign bodies. It has proximal controls (e.g., scissors-like handles), a flexible long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length2300Millimeter
Outer Diameter2.3Millimeter

Contacts#

Phone, Email table
PhoneEmail
+1(800)541-7995regulatory@keysurgical.com

Regulatory Flags#

DUNS number
604056226
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00849771048596NAPlastic Sterilization TrayPST2100SB2023-01-26
00849771048602NAPlastic Sterilization TrayPST3100SB2023-01-26
00849771048619NAPlastic Sterilization TrayPST3200SB2023-01-26
00849771052692NAPlastic Sterilization TrayPST0100SB2023-01-26
00849771052715NAPlastic Sterilization TrayPST3200SBC12023-01-26
00849771052708NAPlastic Sterilization TrayPST1100SB2023-01-26
00849771048626NAPlastic Sterilization TraysPST3300SB2023-05-08
10849771050374NASilicone Clamp CoversVS2012023-03-31
10849771050381NASilicone Clamp CoverVS2022023-01-26
10849771050398NASilicone Clamp CoverVS2032023-01-26
00849771031284Key Surgical Silicone Clamp CoversVS-103VS1032020-12-09
00849771048367NASurgical Plastic InstrumentKS3472023-01-26
00849771048374NASurgical Plastic InstrumentsKS3482023-04-04
10849771013379Key Surgical Cautery Tip CleanerTC200NSTC200NS2025-04-04
10849771047428NAInstrument OrganizerCSDH1002022-11-22
10849771047435NAInstrument OrganizerCSDH1022022-11-22
10849771047442NAInstrument OrganizerCSDH1052022-11-22
10849771047459NAInstrument OrganizerCSDH3002022-11-22
10849771047466NAInstrument OrganizerCSDH2002022-11-22
10849771047473NAInstrument OrganizerCSDH5052022-11-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776430993MillenniumAvalign Technologies, Inc.GDJ2026-09-18
00190776426705MillenniumAvalign Technologies, Inc.GDJ2026-08-19
00850088713459PRINCETONPrinceton Medical Group, Inc.GDJ2026-08-14
00850088713466PRINCETONPrinceton Medical Group, Inc.GDJ2026-08-14
00850088713527PRINCETONPrinceton Medical Group, Inc.GDJ2026-08-14
00190776424497MillenniumAvalign Technologies, Inc.GDJ2026-08-07
03701089543286AMPLITUDEAMPLITUDE SASGDJ2026-07-29
00190776422196MillenniumAvalign Technologies, Inc.GDJ2026-07-28
B382SD9055891030Surgical DirectSurgical Direct, Inc.GDJ2026-07-28
B382SD905589105T0Surgical DirectSurgical Direct, Inc.GDJ2026-07-28
00859261006265VBAS Extension ArmVYCOR MEDICAL, INC.GDJ2026-07-27
04059453072832Hermann Medizintechnik GmbHHermann Medizintechnik GmbHGDJ2026-07-13
00850083275150Intrace USAPILOTIS TECH LLCGDJ2026-07-03
B8034906020ORTHOMEDORTHO-MED, INC.GDJ2026-06-22
B8034906040ORTHOMEDORTHO-MED, INC.GDJ2026-06-22
B8034906060ORTHOMEDORTHO-MED, INC.GDJ2026-06-22
B8034906080ORTHOMEDORTHO-MED, INC.GDJ2026-06-22
B8034906100ORTHOMEDORTHO-MED, INC.GDJ2026-06-22
B8034906180ORTHOMEDORTHO-MED, INC.GDJ2026-06-22
B8034906200ORTHOMEDORTHO-MED, INC.GDJ2026-06-22
B8034906220ORTHOMEDORTHO-MED, INC.GDJ2026-06-22
B8034906240ORTHOMEDORTHO-MED, INC.GDJ2026-06-22
B8034906260ORTHOMEDORTHO-MED, INC.GDJ2026-06-22
04052536085651neon3Ulrich GmbH & Co. KGGDJ2026-06-08
B7685610100Buxton BioMedicalBUXTON BIOMEDICAL, INC.GDJ2025-03-27
B7685610460Buxton BioMedicalBUXTON BIOMEDICAL, INC.GDJ2025-01-10
B7685610500Buxton BioMedicalBUXTON BIOMEDICAL, INC.GDJ2025-01-10
B7685610300Buxton BioMedicalBUXTON BIOMEDICAL, INC.GDJ2024-08-23
B7685614210Buxton BioMedicalBUXTON BIOMEDICAL, INC.GDJ2024-05-31
B7685610440Buxton BioMedicalBUXTON BIOMEDICAL, INC.GDJ2024-04-17