FDA.reportPublic FDA data

Shinva

Primary DI
06936894734100
Brand
Shinva
Company
Xinhua Surgical Instrument Co., Ltd.
Model
ZR1836RBs
Device description
gracey curette 11-12#, double ended, silicone handle
Published
2023-12-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe

Product Codes#

Code, Name table
CodeName
LRWScissors, General, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRWScissors, General, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06936894734100PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06936894734100069368947341006936894734100

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose surgical scissors, reusableA hand-held manual surgical instrument designed to cut/dissect a variety of tissues during open surgery and having no dedication to a specific anatomy or clinical use; it might in addition be intended for cutting materials associated with surgery (e.g., sutures). It is comprised of two pivoted shearing blades with handles, whereby the blades cut as the sharpened edges pass one another as they are closed; some types may have blades that cross over to expose a sharp edge for slicing tissue like a scalpel. It is typically made of metal and is available in various designs and sizes, and some types can have carbide inserts along the cutting edges. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
528755077
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06936506396993ShinvaZR1102RB2023-12-19
06936506397181ShinvaZR1151RB2023-12-19
06936506397716ShinvaZR1374RB2023-12-19
06936506397976ShinvaZR1425RB2023-12-19
06936506398102ShinvaZR1451RB2023-12-19
06936506398249ShinvaZR1541R2023-12-19
06936506398256ShinvaZR1542R2023-12-19
06936506398577ShinvaZR1723R2023-12-19
06936506398928ShinvaZR1851R2023-12-19
06936506399666ShinvaZR2131R2023-12-19
06936506399673ShinvaZR2139R2023-12-19
06936894733820ShinvaZR1362RB2023-12-19
06936894733837ShinvaZR1363RB2023-12-19
06936894733912ShinvaZR1541RBs2023-12-19
06936894733929ShinvaZR1542RBs2023-12-19
06936894734018ShinvaZR1723RBs2023-12-19
06936894734070ShinvaZR1833RBs2023-12-19
06936894734087ShinvaZR1834RBs2023-12-19
06936894734117ShinvaZR1837RBs2023-12-19
06936894744376ShinvaZR1784RB2023-12-19

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