FDA.reportPublic FDA data

Key Surgical Foreign Body Retrievers

Primary DI
00849771041115
Brand
Key Surgical Foreign Body Retrievers
Company
KEY SURGICAL, INC.
Model
EN10178B
Device description
Retrieval Net, 1.8mm Diam, 1600mm L, 30mm (Net) W, 25mm (Net) H
Published
2020-08-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
00849771041115PackageGS110In Commercial Distribution
00849771039907PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849771041115008497710411158497710411150849771041115
00849771039907008497710399078497710399070849771039907

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
Height30Millimeter
Length1600Millimeter
Outer Diameter1.8Millimeter
Width15Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800.541.7995regulatory@keysurgical.com
+1(800)541-7995regulatory@keysurgical.com

Regulatory Flags#

DUNS number
604056226
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
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
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
10849771050374NAKEY SURGICAL, INC.GDJ2023-03-31
G25003048090Backhaus Towel Forceps 9cmN S SURGICAL COMPANYGDJ2023-01-31
G25003048110Backhaus Towel Forceps 11cmN S SURGICAL COMPANYGDJ2023-01-31
G25003048130Backhaus Towel Forceps 13cmN S SURGICAL COMPANYGDJ2023-01-31
10849771050381NAKEY SURGICAL, INC.GDJ2023-01-26
10849771050398NAKEY SURGICAL, INC.GDJ2023-01-26
14026704789570PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704789662PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704789679PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704791160PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704791177PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704791184PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704791191PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704791276PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704791283PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704791290PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704791306PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704791566PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704791573PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704791634PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
10886982311146NASynthes GmbHGDJ2022-11-29
10886982311153NASynthes GmbHGDJ2022-11-29
10886982311160NASynthes GmbHGDJ2022-11-29
10886982311177NASynthes GmbHGDJ2022-11-29
ESOT001972NAS & T AGGDJ2022-09-15
ESOT001982NAS & T AGGDJ2022-09-15
ESOT002452NAS & T AGGDJ2022-09-15
ESOT002462NAS & T AGGDJ2022-09-15
ESOT002862NAS & T AGGDJ2022-09-15
ESOT002871NAS & T AGGDJ2022-09-15