FDA.reportPublic FDA data

DEWIN

Primary DI
36972962310273
Brand
DEWIN
Company
DonneVie Medical Technology(Shanghai)Co.Ltd
Model
D-BIOX
Catalog number
9205-30-7
Device description
Micromanipulation pipette is a disposable sterile product made of borosilicate glass for in vitro cell manipulation.The D-BIOX pipette is used to remove polar bodies or blastomere or trophectoderm cells from embryos for PGD/PGS.
Published
2023-05-22
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

Product Codes#

Code, Name table
CodeName
PUCMicrotools, Assisted Reproduction (Pipettes), Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUCMicrotools, Assisted Reproduction (Pipettes), ExemptObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
36972962310273PackageGS110In Commercial Distribution
16972962310279PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3697296231027336972962310273
1697296231027916972962310279

GMDN Terms#

Term, Definition table
TermDefinition
User-induced micropipetteA long, thin tube made of glass or plastic typically used in the laboratory for the manual withdrawal, transfer, and injection of minute volumes of fluid materials (e.g., microlitres or smaller). The user will typically attach a mouthpiece and create a partial vacuum within the device by gently sucking the air from inside the tube, inducing the substance to enter the device, or achieve the same action with a sqeezable bulb/syringe. Closing the mouthpiece or the user end of the pipette will hold the substance therein; dispensing is done by controlled venting of air into the user end or squeezing the bulb/syringe. Device use may include in vitro fertilization (IVF) procedures.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
554479334
Device count
1
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
true
Expiration date on label
true
Donation ID number
false
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
16972962310170DEWIND-HOLD9203-35-72024-07-15
16972962310712DEWIND-ICSI9207-20-62024-07-15
16972962310934DEWIND-HOLD9218-35-72024-07-15
16972962311351DEWIND-BIOX9222-35-72024-07-15
16972962311375DEWIND-BIOX9223-30-72024-07-15
16972962311634DEWIND-DENU9212-1352024-07-15
16972962311795DEWIND-DENU9212-225P2024-07-15
16972962311962DEWIND-HPZD9228-30-5.52024-07-15
16972962310040DEWIND-ICSI9201-30-102024-07-15
36972962310174DEWIND-HOLD9203-35-72024-07-15
36972962310716DEWIND-ICSI9207-20-62024-07-15
16972962310729DEWIND-ICSI9207-20-82024-07-15
36972962310938DEWIND-HOLD9218-35-72024-07-15
36972962311355DEWIND-BIOX9222-35-72024-07-15
36972962311379DEWIND-BIOX9223-30-72024-07-15
36972962311638DEWIND-DENU9212-1352024-07-15
36972962311799DEWIND-DENU9212-225P2024-07-15
36972962311966DEWIND-HPZD9228-30-5.52024-07-15
16972962310422DEWIND-HOLD9217-35-72023-09-25
16972962310439DEWIND-BIOX9221-35-72023-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10816633020776SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020783SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020790SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020806SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020813SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020820SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020837SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020844SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020851SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020868SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020875SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020899SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020905SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020912SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020929SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020936SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020943SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020950SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020967SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020974SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020981SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020998SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633021957SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633021964SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633021971SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633021988SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633021995SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633022497SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633022503SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633022510SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27