Feel Ject(FIS-024, U-100, 0.5cc, 32G x 8mm)

GUDID 08800045102057

Feel Tech Bio Co., Ltd.

Insulin syringe/needle, basic
Primary Device ID08800045102057
NIH Device Record Key2da4e44d-a17d-4e38-9660-873b82a67971
Commercial Distribution StatusIn Commercial Distribution
Brand NameFeel Ject(FIS-024, U-100, 0.5cc, 32G x 8mm)
Version Model NumberFIS-024
Company DUNS694632098
Company NameFeel Tech Bio Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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
GS108800045102040 [Primary]
GS108800045102057 [Package]
Contains: 08800045102040
Package: INBOX [100 Units]
In Commercial Distribution
GS108800045107397 [Package]
Package: CARTONBOX [3000 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMFSyringe, Piston

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-16
Device Publish Date2026-02-06

Devices Manufactured by Feel Tech Bio Co., Ltd.

08800045101906 - Feel Ject(FIS-019, U-100, 0.3cc, 32G x 8mm)2026-02-16
08800045102057 - Feel Ject(FIS-024, U-100, 0.5cc, 32G x 8mm)2026-02-16
08800045102057 - Feel Ject(FIS-024, U-100, 0.5cc, 32G x 8mm)2026-02-16
08800045102200 - Feel Ject(FIS-029, U-100, 1.0cc, 32G x 8mm)2026-02-16
08800045102538 - Feel Ject(FIS-039, U-100, 0.3cc, 31G x 6mm)2026-02-16
08800045105201 - Feel Ject(FIS-203, U-100, 0.3 cc, 30G x 12.7mm)2026-02-16
08800045105232 - Feel Ject(FIS-204, U-100, 0.3cc, 30G x 8mm)2026-02-16
08800045105478 - Feel Ject(FIS-212, U-100, 1.0cc, 30G x 8mm)2026-02-16
08800045105652 - Feel Ject(FIS-2502, U-100, 0.5 cc, 30G x 8mm)2026-02-16

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