FDA.reportPublic FDA data

Single Use Grasping Forceps

Primary DI
06970401810581
Brand
Single Use Grasping Forceps
Company
Zhejiang Chuangxiang Medical Technology Co., LTD.
Model
MD-B-GF1812
Device description
Coating plastic on the spring tube.
Published
2023-02-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OCZEndoscopic Grasping/Cutting Instrument, Non-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCZEndoscopic Grasping/Cutting Instrument, Non-PoweredGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191900000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191900000Single Use Grasping ForcepsZhejiang Chuangxiang Medical Technology Co., Ltd.2020-03-27OCZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970401810581PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970401810581069704018105816970401810581

GMDN Terms#

Term, Definition table
TermDefinition
Flexible endoscopic tissue manipulation forceps, single-useA flexible, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope to grasp tissue (typically atraumatically), or additionally foreign bodies. It has proximal controls (e.g., scissors-like handles), a flexible long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544434963
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06936534328911Polypectomy Snare (NON-ELECTRICAL)MD-E-FL1810242026-09-29
06936534328928Polypectomy Snare (NON-ELECTRICAL)MD-E-FL1810182026-09-29
06936534328935Polypectomy Snare (NON-ELECTRICAL)MD-E-FL1815242026-09-29
06936534328942Polypectomy Snare (NON-ELECTRICAL)MD-E-FL1815182026-09-29
06936534328959Polypectomy Snare (NON-ELECTRICAL)MD-E-FL1825242026-09-29
06936534328966Polypectomy Snare (NON-ELECTRICAL)MD-E-FL1825182026-09-29
06936534328973Polypectomy Snare (NON-ELECTRICAL)MD-E-FL2410242026-09-29
06936534328980Polypectomy Snare (NON-ELECTRICAL)MD-E-FL2410182026-09-29
06936534328997Polypectomy Snare (NON-ELECTRICAL)MD-E-FL2415242026-09-29
06936534329000Polypectomy Snare (NON-ELECTRICAL)MD-E-FL2415182026-09-29
06936534329017Polypectomy Snare (NON-ELECTRICAL)MD-E-FL2425242026-09-29
06936534329024Polypectomy Snare (NON-ELECTRICAL)MD-E-FL2425182026-09-29
06936534329031Polypectomy Snare (NON-ELECTRICAL)MD-H-FL1810242026-09-29
06936534329048Polypectomy Snare (NON-ELECTRICAL)MD-H-FL1810182026-09-29
06936534329055Polypectomy Snare (NON-ELECTRICAL)MD-H-FL1815242026-09-29
06936534329062Polypectomy Snare (NON-ELECTRICAL)MD-H-FL1815182026-09-29
06936534329079Polypectomy Snare (NON-ELECTRICAL)MD-H-FL1825242026-09-29
06936534329086Polypectomy Snare (NON-ELECTRICAL)MD-H-FL1825182026-09-29
06936534329093Polypectomy Snare (NON-ELECTRICAL)MD-H-FL2410242026-09-29
06936534329109Polypectomy Snare (NON-ELECTRICAL)MD-H-FL2410182026-09-29

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Primary DI, Brand, Company table
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