FDA.reportPublic FDA data

Histolock

Primary DI
10724995182882
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
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
10724995182882PackageGS13In 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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
627879687
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
false
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
00724995182557Exacto00711094007110942021-03-31
00724995182564Exacto00711095007110952021-03-31
00724995182618Exacto00711115007111152021-03-31
00724995243746Exacto Mundo00711114007111142025-01-31
00724995180959VIA00717001007170012020-01-31
00724995181116VIA00717019007170192020-01-30
00724995181420VIA00717051007170512020-01-30
00724995181451VIA00717054007170542020-01-30
00724995181505VIA00717059007170592020-01-30
00724995181659VIA00717076007170762020-01-30
00724995182984VIA00717141007171412020-01-30
00724995183073VIA00717155007171552020-07-16
00724995183141VIA00717167007171672020-01-30
00724995183257VIA00717182007171822020-01-30
00724995190699VIA00717223007172232020-01-30
00724995190736VIA00717234007172342020-01-30
00724995193966VIA00717269007172692020-02-04
00724995194123VIA00717229007172292020-02-07
00724995194987VIA00717310007173102020-03-23
00724995203412VIA00717337007173372020-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00849233014817Busse Hospital DisposablesROBERT BUSSE & CO., INC.PRV2026-04-27
00849233013575Busse Hospital DisposablesROBERT BUSSE & CO., INC.PRV2025-06-23
10849233013572Busse Hospital DisposablesROBERT BUSSE & CO., INC.PRV2025-06-23
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
00724995182885HistolockUS EndoscopyPRV2020-04-02
00724995182892HistolockUS EndoscopyPRV2020-04-02
10724995182899HistolockUS EndoscopyPRV2020-04-02
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