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DemeLON Multi NM10604

by DemeTECH Corp

DemeLON Multi NM10604 is a Class II device made by DemeTECH Corp, cleared under FDA 510(k) K023028 on 18 Jun 2003 and listed in FDA GUDID since 12 Jul 2019 (UDI-DI 10652927420422), active as of 23 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 23 Oct 2026

Documents

510(k) K023028

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10652927420422 UDI-DI Date12 Jul 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK023028 Date18 Jun 2003DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K023028 decided 18 Jun 2003 Active
  • FDA GUDID UDI-DI 10652927420422 listed 12 Jul 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K023028
  2. Listed FDA GUDID 10652927420422

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
DemeLON Multi
Generic name
Nylon suture, non-bioabsorbable, multifilament, non-antimicrobial
Model / reference
NM10604
Primary DI / UDI-DI
10652927420422
510(k) Number
FDA product code
GAR
GMDN term
Nylon suture, non-bioabsorbable, multifilament, non-antimicrobial
Device class
Class II
Regulation number
878.5020
GUDID distribution status
In Commercial Distribution

Similar devices in this category

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Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)