FDA.reportPublic FDA data

MT

Primary DI
16932503540381
Brand
MT
Company
Micro-Tech (Nanjing) Co., Ltd.
Model
100578
Catalog number
100578
Device description
Normal handle, Oval, without spike, Single outer sheath, FEP coated, Two Wire, 2.3*2300 mm
Published
2020-03-23
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
16932503540381PackageGS110In Commercial Distribution
26932503540388PackageGS1100In Commercial Distribution
06932503540384PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693250354038116932503540381
2693250354038826932503540388
06932503540384069325035403846932503540384

GMDN Terms#

Term, Definition table
TermDefinition
Rigid endoscopic biopsy forceps, single-useA rigid, manual, non-electrosurgical instrument intended to obtain tissue specimens during endoscopic procedures (e.g., laparoscopy, thoracoscopy, spinoscopy, arthroscopy). It is typically constructed as a long instrument with one sliding and one stationary rod whose distal ends are equipped with 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
Length230Centimeter
Lumen/Inner Diameter2.8Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877-552-4027info@micro-tech-usa.com

Regulatory Flags#

DUNS number
530269083
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
06932503563857Additional Working ChannelEZS011752026-09-30
06932503563864Additional Working ChannelEZS114752026-09-30
06932503563871Additional Working ChannelEZS217802026-09-30
06932503516563Sphincterotome / short-wire compatibleRDSP-0230-231-22026-06-27
06932503540353Disposable Biopsy Forceps1005751005752020-03-23
06932503540360Disposable Biopsy Forceps1005761005762020-03-23
06932503540377Disposable Biopsy Forceps1005771005772020-03-23
06932503540384Disposable Biopsy Forceps1005781005782020-03-23
06932503510219Pulmonary Hydro-Slide GuidewireGW-35/182026-05-29
06932503510226Pulmonary Hydro-Slide GuidewireGW-35/262026-05-29
06932503563772eyeMAX(TM) Single-use Video Pancreaticobiliary ScopeCDS220092026-05-15
06932503516112Sphincterotome / short-wire compatibleRDSP-0525-121-12026-05-08
06932503516129Sphincterotome / short-wire compatibleRDSP-0525-221-12026-05-08
06932503516136Sphincterotome / short-wire compatibleRDSP-0525-131-12026-05-08
06932503516143Sphincterotome / short-wire compatibleRDSP-0525-231-12026-05-08
06932503516150Sphincterotome / short-wire compatibleRDSP-0530-111-12026-05-08
06932503516167Sphincterotome / short-wire compatibleRDSP-0530-211-12026-05-08
06932503516174Sphincterotome / short-wire compatibleRDSP-0530-121-12026-05-08
06932503516181Sphincterotome / short-wire compatibleRDSP-0530-221-12026-05-08
06932503516198Sphincterotome / short-wire compatibleRDSP-0530-131-12026-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06936603211908Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06936603211953Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06936603211977Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06936603212059Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06936603212103Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06936603224878Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06936603224885Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06936603224892Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06936603224908Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06936603224915Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06936603224939Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06936603230817Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06975339628871Single-Use Biopsy ForcepsMacroLux Medical Technology Co., Ltd.FCL2026-10-19
B382SD379410Surgical DirectSurgical Direct, Inc.FCL2026-10-15
06934415027274ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027281ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027298ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027304ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027311ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027328ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027335ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027342ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027557ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027564ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027571ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027588ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027595ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027601ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027618ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027625ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30