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Mindray NGB-063-DK

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

Mindray NGB-063-DK (11485) is a Class II device made by JingFang Precision Medical Device(Shenzhen) Co., Ltd., listed in FDA GUDID since 2 Jun 2026 (UDI-DI 06975122554851), registry data as of 22 Oct 2026.

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

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06975122554851 UDI-DI Date2 Jun 2026ListedStatusListed 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  • Withdrawn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
Mindray
Generic name
Needle guide, single-use
Model / Ref / Catalog
NGB-063-DK, 11485
Primary DI / UDI-DI
06975122554851
FDA product code
OIJ
GMDN term
Needle guide, single-use
Device class
Class II
Regulation number
892.1560
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code OIJ (Biopsy Needle Guide Kit).

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

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

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (7, all answered No)