FDA.reportPublic FDA data

Bone Biopsy Device

Primary DI
06938695537874
Brand
Bone Biopsy Device
Company
Shanghai Kinetic Medical Co., Ltd.
Model
BC1111
Catalog number
BC1111
Device description
Bone Biopsy Device, Square, 9G (3.5mm)
Published
2020-05-31
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
MJGDevice, Percutaneous, Biopsy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MJGDevice, Percutaneous, BiopsyGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06938695537874PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06938695537874069386955378746938695537874

GMDN Terms#

Term, Definition table
TermDefinition
Bone grafting cannulaA rigid tube intended to be used surgically to introduce a bone void filler (e.g., a bone matrix implant/bone substitute) in voids or gaps of the skeletal system (i.e., extremities, craniofacial bone, spine, and pelvis) to fill defects in the bone structure created surgically or traumatically. It is typically made of metal materials (e.g., high-grade stainless steel) with or without a plastic hub at the distal end to connect to a syringe or other device that propels the filler. The device may also be used for the delivery of orthopaedic cement. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter3.5Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature18 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+862150720558qingmeiwei@kineticmedinc.com

Regulatory Flags#

DUNS number
528198569
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06938695502155Bone DrillFG27012025-12-09
06938695502254CannulaFG22032025-12-09
06938695521026DrillFG21002025-12-09
06938695527004Bone DrillFG27002025-12-09
06938695522009CannulaFG2200FG22002016-12-05
06938695524003DilatorFG2400FG24002016-12-05
06938695530066Puncture NeedleFG3006FG30062016-05-26
06938695537676Dilator w/CannulaFG2410FG24102020-05-31
06938695546067KMC Guide Wire, 1.6mm, Blunt TipKMC-000-002020-10-01
06938695546074KMC Guide Wire, 1.6mm, Sharp TipKMC-000-102020-10-01
06938695546081KMC Access Needle, 11 Gauge, 95mm, Bevel TipKMC-001-002020-10-01
06938695546098KMC Access Needle, 11 Gauge, 95mm, Pyramid TipKMC-001-102020-10-01
06938695546104KMC Access Needle, 11 Gauge, 115mm, Pyramid TipKMC-001-112020-10-01
06938695546111KMC Access Needle, 11 Gauge, 115mm, Integrated Diamond TipKMC-001-202020-10-01
06938695546128KMC Access Needle, 11 Gauge, 115mm, Integrated Bevel TipKMC-001-302020-10-01
06938695546135KMC Access Needle, 13 Gauge, 95mm, Pyramid TipKMC-002-002020-10-01
06938695546142KMC Access Needle, 13 Gauge, 115mm, Pyramid TipKMC-002-012020-10-01
06938695546159KMC Access Needle, 13 Gauge, 115mm, Integrated Bevel TipKMC-002-102020-10-01
06938695546166KMC Balloon Catheter, 8 Gauge, 10mmKMC-003-102020-10-01
06938695546173KMC Balloon Catheter, 8 Gauge, 15mmKMC-003-152020-10-01

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