FDA.reportPublic FDA data

Centra

Primary DI
10724995180642
Brand
Centra
Company
US Endoscopy
Model
00711250
Catalog number
00711250
Device description
The Centra biopsy forceps is used to enter human gastrointestinal tract via flexible endoscope to obtain tissue sample in order to understand disease pathology.
Published
2021-03-31
Public version status
New
Distribution status
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
FCLFORCEPS, BIOPSY, NON-ELECTRIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCLForceps, Biopsy, Non-ElectricGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10724995180642PackageGS110In Commercial Distribution
00724995180645PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1072499518064210724995180642
00724995180645007249951806457249951806450724995180645

GMDN Terms#

Term, Definition table
TermDefinition
Flexible endoscopic biopsy forceps, single-useA flexible, manual, non-electrosurgical instrument intended to obtain tissue specimens during endoscopic procedures (e.g., gastro-urological endoscopy, laparoscopy, bronchoscopy, laryngoscopy) for histopathological examination. It is typically a flexible metal coil with a pair of scissors-like cups with cutting edge rims, which are operated by a control handle at the proximal end of the instrument. It is introduced into the body through an artificial orifice of the body or the working channel of the endoscope. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length2300Millimeter
Outer Diameter2.1Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling 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
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
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
08809909421723Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421730Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421747Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421754Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421761Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421778Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421785Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421792Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421808Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421815Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421822Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421839Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421846Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421853Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421860Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421877Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421884Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421891Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421907Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421914Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421921Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421938Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421945Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421952Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421969Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421976Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421983Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421990Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08051887049837THD BIOPSYTHD SPAFCL2026-01-07
08051887049851THD BIOPSYTHD SPAFCL2026-01-07