FDA.reportPublic FDA data

Histolock

Primary DI
00724995182885
Brand
Histolock
Company
US Endoscopy
Model
00711872
Catalog number
00711872
Device description
The Histolock resection kit (4-piece) contains the devices needed for injecting, resecting, and collecting flat lesions. The kit is made up of the Histolock Resection Device, Carr-Locke injection needle, eTrap polyp trap and Mio medical device organizer.
Published
2020-04-02
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PRVGastro-urology biopsy kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PRVGastro-Urology Biopsy KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10724995182882PackageGS13Not in Commercial Distribution
00816765012833PreviousGS10
00724995182885PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1072499518288210724995182882
00816765012833008167650128338167650128330816765012833
00724995182885007249951828857249951828850724995182885

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose endoscopic needle, single-useA flexible, sterile, sharp bevel-edged, hollow tubular device intended to be manually-operated through a compatible endoscope to perform various needle functions (e.g., injection, aspiration, irrigation, puncture) during endoscopy. It is designed with appropriate shape, materials, gauge, and other characteristics (e.g., high-contrast tips) to function through the working channel of an endoscope. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
627879687
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10724995184015Endo-Boot00711621007116212020-04-01
10724995184022Endo-Boot00711622007116222020-04-01
00724995190637ProArmor00711623007116232020-07-16
00724995190644ProArmor00711624007116242020-07-16
00724995180355NA3905133905132020-04-02
00724995180362CO2MPACT7103007103002020-04-02
00724995180386NA7103047103042020-04-02
00724995180409NA7104247104242020-04-02
00724995180416NA7104257104252020-04-02
00724995180423NA7104267104262020-04-02
00724995180430NA7106027106022020-04-02
00724995180447NA7106037106032020-04-02
00724995180454NA7106047106042020-04-02
00724995180522Torrent00711579007115792020-04-01
00724995180768UltramatrixUSBOLUSBOL2020-04-02
00724995180775UltramatrixUSBORUSBOR2020-04-02
00724995180782iSnare00711084007110842020-03-19
00724995180843Articulator00711804007118042020-04-01
00724995182472Short Throw00711018007110182020-03-19
00724995182489Short Throw00711019007110192020-03-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00849233014817Busse Hospital DisposablesROBERT BUSSE & CO., INC.PRV2026-04-27
10885380187902Aero-MedAERO-MED, LLCPRV2026-02-20
10885380189159Aero-MedAERO-MED, LLCPRV2026-02-20
00849233013575Busse Hospital DisposablesROBERT BUSSE & CO., INC.PRV2025-06-23
10849233013572Busse Hospital DisposablesROBERT BUSSE & CO., INC.PRV2025-06-23
10885380202605Aero-MedAERO-MED, LLCPRV2024-05-10
10885380195365Aero-MedAERO-MED, LLCPRV2023-04-20
10885380194733Aero-MedAERO-MED, LLCPRV2023-02-24
00849233002012Busse Hospital DisposablesROBERT BUSSE & CO., INC.PRV2020-11-23
00849233013827Busse Hospital DisposablesROBERT BUSSE & CO., INC.PRV2020-11-23
10849233002019Busse Hospital DisposablesROBERT BUSSE & CO., INC.PRV2020-11-23
10849233013824Busse Hospital DisposablesROBERT BUSSE & CO., INC.PRV2020-11-23
00849233015401Busse Hospital DisposablesROBERT BUSSE & CO., INC.PRV2020-04-08
00724995182892HistolockUS EndoscopyPRV2020-04-02
10724995182882HistolockUS EndoscopyPRV2020-04-02
10724995182899HistolockUS EndoscopyPRV2020-04-02
00724995182540Polyp PakUS EndoscopyPRV2020-03-19
00849233001770Busse Hospital DisposablesROBERT BUSSE & CO., INC.PRV2016-09-16
00849233001787Busse Hospital Disposables ROBERT BUSSE & CO., INC.PRV2016-09-16
00849233009967Busse Hospital DisposablesROBERT BUSSE & CO., INC.PRV2016-09-15
00849233009943Busse Hospital DisposablesROBERT BUSSE & CO., INC.PRV2016-09-13
00849233009950Busse Hospital DisposablesROBERT BUSSE & CO., INC.PRV2016-09-13
00849233013261Busse Hospital DisposablesROBERT BUSSE & CO., INC.PRV2016-09-02
00849233013803Busse Hospital DisposablesROBERT BUSSE & CO., INC.PRV2016-09-02
00849233013834Busse Hospital DisposablesROBERT BUSSE & CO., INC.PRV2016-09-02
00849233013278Busse Hospital Disposables ROBERT BUSSE & CO., INC.PRV2016-09-02
00849233013285Busse Hospital DisposablesROBERT BUSSE & CO., INC.PRV2016-09-02
00849233013292Busse Hospital DisposablesROBERT BUSSE & CO., INC.PRV2016-09-02
10849233013831Busse Hospital DisposablesROBERT BUSSE & CO., INC.PRV2016-09-02
00849233013841Busse Hospital DisposablesROBERT BUSSE & CO., INC.PRV2016-09-02