FDA.reportPublic FDA data

MT

Primary DI
16932503548547
Brand
MT
Company
Micro-Tech (Nanjing) Co., Ltd.
Model
HBF65-11023230
Device description
Alligator, without spike, 2.3*2300 mm
Published
2021-12-31
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
KGEForceps, Biopsy, Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGEForceps, Biopsy, ElectricGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180018000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180018000Disposable Hot Biopsy ForcepsMicro-Tech (Nanjing) Co., Ltd.2018-07-05KGE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16932503548547PackageGS110In Commercial Distribution
26932503548544PackageGS110In Commercial Distribution
06932503548540PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693250354854716932503548547
2693250354854426932503548544
06932503548540069325035485406932503548540

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical handpiece/electrode, monopolar, single-useA sterile electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece and may include a lumen for suction/irrigation; it requires a patient contact return electrode to complete the circuit. It is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe with controls) and may be designed to also mechanically cut tissues. 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
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
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
06932503516204Sphincterotome / short-wire compatibleRDSP-0530-231-12026-05-08
06932503575379Sphincterotome / short-wire compatibleRDSP-0220-1112026-05-08
06932503575386Sphincterotome / short-wire compatibleRDSP-0220-2112026-05-08
06932503575393Sphincterotome / short-wire compatibleRDSP-0220-1212026-05-08
06932503575409Sphincterotome / short-wire compatibleRDSP-0220-2212026-05-08
06932503575416Sphincterotome / short-wire compatibleRDSP-0220-1312026-05-08
06932503575423Sphincterotome / short-wire compatibleRDSP-0220-2312026-05-08
06932503575430Sphincterotome / short-wire compatibleRDSP-0225-1112026-05-08
06932503575447Sphincterotome / short-wire compatibleRDSP-0225-2112026-05-08
06932503575454Sphincterotome / short-wire compatibleRDSP-0225-1212026-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06959664913871NAHangzhou AGS MedTech Co., Ltd.KGE2026-04-15
06959664913888NAHangzhou AGS MedTech Co., Ltd.KGE2026-04-15
06959664913895NAHangzhou AGS MedTech Co., Ltd.KGE2026-04-15
06959664913901NAHangzhou AGS MedTech Co., Ltd.KGE2026-04-15
06959664913918NAHangzhou AGS MedTech Co., Ltd.KGE2026-04-15
06959664913925NAHangzhou AGS MedTech Co., Ltd.KGE2026-04-15
06959664913932NAHangzhou AGS MedTech Co., Ltd.KGE2026-04-15
06959664913949NAHangzhou AGS MedTech Co., Ltd.KGE2026-04-15
06959664913956NAHangzhou AGS MedTech Co., Ltd.KGE2026-04-15
06959664913963NAHangzhou AGS MedTech Co., Ltd.KGE2026-04-15
06959664913970NAHangzhou AGS MedTech Co., Ltd.KGE2026-04-15
06959664913987NAHangzhou AGS MedTech Co., Ltd.KGE2026-04-15
04953170466038Single Use Electrosurgical Hemostatic ForcepsOLYMPUS MEDICAL SYSTEMS CORP.KGE2026-04-01
04953170466182Single Use Electrosurgical Hemostatic ForcepsOLYMPUS MEDICAL SYSTEMS CORP.KGE2026-04-01
04953170466267Single Use Electrosurgical Hemostatic ForcepsOLYMPUS MEDICAL SYSTEMS CORP.KGE2026-04-01
08809327353293ClearHemograsperFINEMEDIX CO.,LTD.KGE2026-03-24
08809327353316ClearHemograsperFINEMEDIX CO.,LTD.KGE2026-03-24
08809327353323ClearHemograsperFINEMEDIX CO.,LTD.KGE2026-03-24
08809327355518ClearHemograsperFINEMEDIX CO.,LTD.KGE2026-03-24
08809327355808ClearHemograsperFINEMEDIX CO.,LTD.KGE2026-03-24
18809327353290ClearHemograsperFINEMEDIX CO.,LTD.KGE2026-03-24
18809327353313ClearHemograsperFINEMEDIX CO.,LTD.KGE2026-03-24
18809327353320ClearHemograsperFINEMEDIX CO.,LTD.KGE2026-03-24
18809327355515ClearHemograsperFINEMEDIX CO.,LTD.KGE2026-03-24
18809327355805ClearHemograsperFINEMEDIX CO.,LTD.KGE2026-03-24
04953170466243DISPOSABLE HOT BIOPSY FORCEPSOLYMPUS MEDICAL SYSTEMS CORP.KGE2025-11-19
04953170466250DISPOSABLE HOT BIOPSY FORCEPSOLYMPUS MEDICAL SYSTEMS CORP.KGE2025-11-19
06934415022309ZKSKBeijing ZKSK Technology Co.,LtdKGE2023-12-19
06934415022316ZKSKBeijing ZKSK Technology Co.,LtdKGE2023-12-19
06934415022323ZKSKBeijing ZKSK Technology Co.,LtdKGE2023-12-19