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InnoFine JEM-018

by JingFang Precision Medical Device(Shenzhen) Co., Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06971554720185 UDI-DI Date4 Sep 2020ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
InnoFine
Generic name
Needle guide, reusable
Model / reference
JEM-018
Primary DI / UDI-DI
06971554720185
FDA product code
OIJ
GMDN term
Needle guide, reusable
Device class
Class II
Regulation number
892.1560
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Needle guide, reusable

Other devices from JingFang Precision Medical Device(Shenzhen) Co., Ltd.

See all devices from JingFang Precision Medical Device(Shenzhen) Co., Ltd. →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Serial number
  • Manufacturing date

Other properties (10)

  • Supplied sterile: No
  • Single use: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Lot / batch number: No
  • Expiration date: No