SLM

Primary DI
30816633022095
Brand
SLM
Company
SUNLIGHT MEDICAL, INC.
Model
SHP-100-30
Device description
Holding Pipette
Published
2016-09-24
Public version status
Update
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072600000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072600000INTRACYTOPLASMIC SPERM AND SPERMATID INJECTION, HOLDING, ZONE DRILLING, PARTIAL ZONE DISSECTION AND DENUDING PIPETTESSunlight Medical, Inc.2008-05-19MQH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30816633022095PackageGS110In Commercial Distribution
10816633022091PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3081663302209530816633022095
1081663302209110816633022091

GMDN Terms#

Term, Definition table
TermDefinition
Mechanical pipetteA manually-operated device typically used in the laboratory to withdraw, transfer, and inject discrete volumes of fluid materials. The device is typically hand-held and operates through an internal mechanism powered by the fingers; it can have a single channel or multichannel piston/cylinder pick-up assembly. The device transfers consistent volumes of liquid into one or several receptacles simultaneously (e.g., the wells of a microtitre plate). A pipette may be factory pre-set to deliver a given volume, or may have user-selectable volumes within a useful volume range. The delivered volume may be mechanically indicated.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry, Keep away from sunlight, Store at room temperature

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
039709088
Device count
1
DM exempt
false
Premarket exempt
false
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
10816633020776SLMSIC-45F-20R2024-03-27
10816633020783SLMSIC-45F-35R2024-03-27
10816633020790SLMSIC-45F-45K2024-03-27
10816633020806SLMSIC-55W-252024-03-27
10816633020813SLMSIC-55H-252024-03-27
10816633020820SLMSIC-45W-252024-03-27
10816633020837SLMSIC-45W-202024-03-27
10816633020844SLMSIC-45H-202024-03-27
10816633020851SLMSIC-60V-30L2024-03-27
10816633020868SLMSIC-50T-352024-03-27
10816633020875SLMSIC-60F-35R2024-03-27
10816633020899SLMSIC-60V-302024-03-27
10816633020905SLMSIC-60F-35K2024-03-27
10816633020912SLMSIC-50F-35K2024-03-27
10816633020929SLMSIC-50F-352024-03-27
10816633020936SLMSIC-40V-35L2024-03-27
10816633020943SLMSIC-40V-352024-03-27
10816633020950SLMSIC-50F-45R2024-03-27
10816633020967SLMSIC-50F-10R2024-03-27
10816633020974SLMSIC-90F-302024-03-27

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