FDA.reportPublic FDA data

HWATO Vaccaria seed W/P-50, with Tape

Primary DI
36901452983864
Brand
HWATO Vaccaria seed W/P-50, with Tape
Company
Suzhou Medical Appliance Factory
Model
W/P-50 (50 PCS)
Device description
50 Units in single pack
Published
2023-10-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
KNMDevice, Pressure Applying

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNMDevice, Pressure ApplyingPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
36901452983864PackageGS1200In Commercial Distribution
16901452983860PrimaryGS10
06901452983863Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3690145298386436901452983864
1690145298386016901452983860
06901452983863069014529838636901452983863

GMDN Terms#

Term, Definition table
TermDefinition
Ear microsystem seed/pelletA device used in auriculotherapy (a treatment modality in which the external surface of the ear is stimulated to alleviate pathological conditions in other parts of the body) to apply continuous pressure to stimulate meridian points. The device may be a plant seed (e.g., Vaccaria) or a metal pellet [e.g., stainless steel with or without gold (Au) or silver (Ag) plating], possibly magnetized, typically applied to the ear with adhesive tape. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
653739474
Device count
50
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
false
Expiration date on label
true
Donation ID number
true
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
16901452970099Hua-Xia Basic Acupuncture Needles0.22x40Xb.22x402016-09-15
16901452900010Hwa-To Singles Acupuncture Needles0.20x13Hs.20x132016-09-15
06901452000003HWATO TDP Heat LampTDP11-DL 2017-04-05
16901452648196HWATO Yuezhen - ACA COMFORT NEEDLE0.16X132025-05-08
06901452648199HWATO Yuezhen - ACA COMFORT NEEDLE0.16X132025-05-08
06901452000010HWATO TDP Heat Lamp TDP12-XL2017-04-05
06901452000058HWATO TDP Heat LampTDP22-XL2017-04-05
16901452600330HWATO Yuezhen0.20 x 252017-01-26
16901452600569HWATO Yuezhen0.22 x 402017-01-26
16901452648073HWATO Yuezhen - ACA COMFORT NEEDLE0.25X252017-05-18
16901452648080HWATO Yuezhen - ACA COMFORT NEEDLE0.30X252017-05-18
16901452648097HWATO Yuezhen - ACA COMFORT NEEDLE0.20X402017-05-18
16901452648103HWATO Yuezhen - ACA COMFORT NEEDLE0.22X402017-05-18
16901452648110HWATO Yuezhen - ACA COMFORT NEEDLE0.25X402017-05-18
16901452648127HWATO Yuezhen - ACA COMFORT NEEDLE0.30X402017-05-18
16901452648134HWATO Yuezhen - ACA COMFORT NEEDLE0.20X502017-05-18
16901452648141HWATO Yuezhen - ACA COMFORT NEEDLE0.22X502017-05-18
16901452648158HWATO Yuezhen - ACA COMFORT NEEDLE0.25X502017-05-18
16901452648165HWATO Yuezhen - ACA COMFORT NEEDLE0.30X502017-05-18
16901452648172HWATO Yuezhen - ACA COMFORT NEEDLE0.25X132019-08-15

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Primary DI, Brand, Company table
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