FDA.reportPublic FDA data

Intelligent ICSI Micropipette

Primary DI
00858604006320
Brand
Intelligent ICSI Micropipette
Company
HAMILTON THORNE, INC.
Model
IC.3.45.xx.A
Device description
Micropipette, ICSI, Feature Type 3, 4.5µm
Published
2019-11-20
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
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
00858604006320PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858604006320008586040063208586040063200858604006320

GMDN Terms#

Term, Definition table
TermDefinition
Assisted reproduction microtoolA dedicated pipette or other device used in the laboratory to denude, micromanipulate, hold, or transfer human gametes or embryos for assisted hatching, intracytoplasmic sperm injection (ICSI), or other assisted reproduction methods. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
152161337
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
00858604006061Intelligent ICSI MicropipetteIC.3.90.xx.B2024-12-11
00858604006054LYKOS DTSLYKOS DTS2023-06-07
00858604006276ZILOS-tk™ZILOS-tk2019-11-30
00858604006290LYKOS™LYKOS2019-11-30
00858604006108IVOSIVOS2019-11-30
00858604006719CEROSCEROS2019-11-30
00858604006016accu-beads®accu-beads®2022-03-30
00858604006115GM501 Gradient 45%4GM501GR-45-102021-04-30
00858604006122GM501 Gradient 45%4GM501GR-45-502021-04-30
00858604006139GM501 Gradient 45%4GM501GR-45-1002021-04-30
00858604006221GM501 Gradient 100%4GM501G-100-1002021-04-30
00858604006238GM501 Gradient 100%4GM501G-100-2502021-04-30
00858604006245GM501 Gradient 100%4GM501G-100-5002021-04-30
00858604006146GM501 Gradient 45%4GM501GR-45-2502021-04-30
00858604006177GM501 Gradient 90%4GM501GR-90-102021-04-30
00858604006184GM501 Gradient 90%4GM501GR-90-502021-04-30
00858604006191GM501 Gradient 90%4GM501GR-90-1002021-04-30
00858604006207GM501 Gradient 90%4GM501GR-90-2502021-04-30
00858604006214GM501 Gradient 100%4GM501G-100-502021-04-30
00858604006351Intelligent ICSI MicropipetteIC.4.70.xx.C2020-02-19

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