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Rtn-84-T 8 Ga X 4 in

by Ranfac Corp.

Rtn-84-T 8 Ga X 4 in is a Class II device made by Ranfac Corp., cleared under FDA 510(k) K983187 on 10 Dec 1998 and listed in FDA GUDID since 20 Nov 2023 (UDI-DI 00850023741844), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K983187

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850023741844 UDI-DI Date20 Nov 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK983187 Date10 Dec 1998DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K983187 decided 10 Dec 1998 Active
  • FDA GUDID UDI-DI 00850023741844 listed 20 Nov 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K983187
  2. Listed FDA GUDID 00850023741844

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Rtn-84-T
Generic name
Bone marrow biopsy needle, single-use
Model / Ref / Catalog
8 GA X 4 IN, RTN-84-T
Primary DI / UDI-DI
00850023741844
510(k) Number
FDA product code
KNW
GMDN term
Bone marrow biopsy needle, single-use
Device class
Class II
Regulation number
876.1075
GUDID distribution status
In Commercial Distribution
Size
Length — 4 Inch
Needle Gauge — 8 Gauge

Similar devices in this category

Other devices filed under Bone marrow biopsy needle, single-use.

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Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)