FDA.reportPublic FDA data

NA

Primary DI
10816765011901
Brand
NA
Company
US Endoscopy
Model
00711812
Catalog number
00711812
Device description
The Carr-Locke injection needle is a single use, disposable, flexible sheath injection needle used for the injection of various types of media through flexible endoscopes.
Published
2016-09-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FCGBiopsy needle

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCGBiopsy NeedleGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K971842000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K971842000COAXIAL NEEDLEUnited States Endoscopy Group, Inc.1997-06-20FCG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816765011901PackageGS15Not in Commercial Distribution
00816765011904PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081676501190110816765011901
00816765011904008167650119048167650119040816765011904

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length230Centimeter
Needle Gauge23Gauge
Outer Diameter2.5Millimeter

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
false
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08800025901601BEXCORE Breast Biopsy NeedleMedicalPark CO.,LTD.FCG2026-06-01
08800025901854BEXCORE Breast Biopsy NeedleMedicalPark CO.,LTD.FCG2026-06-01
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08033860041854BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
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08033860041878BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
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08033860041892BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
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08033860041946BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
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08033860002558BIOPSYBELLBIOPSYBELL SRLFCG2023-07-03
08033860017361BIOPSYBELLBIOPSYBELL SRLFCG2023-07-03