SFG ICSI dish

GUDID 00850068289479

SPECTRUM FERTILITY GROUP INC.

Assisted reproduction procedure dish
Primary Device ID00850068289479
NIH Device Record Key70bb24f2-7170-4c31-821d-dcb60cd4ba58
Commercial Distribution StatusIn Commercial Distribution
Brand NameSFG ICSI dish
Version Model NumberS-D-50
Company DUNS119292307
Company NameSPECTRUM FERTILITY GROUP INC.
Device Count500
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850068289479 [Unit of Use]
GS110850068289476 [Primary]

FDA Product Code

PUDLabware, Assisted Reproduction, Exempt

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-20
Device Publish Date2024-11-12

Devices Manufactured by SPECTRUM FERTILITY GROUP INC.

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00850068289042 - SFG Denuding pipettes2024-11-20
00850068289059 - SFG Denuding pipettes2024-11-20
00850068289066 - SFG Denuding pipettes2024-11-20
00850068289073 - SFG Denuding pipettes2024-11-20

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