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DemeBOND PB1145019F4P

by DemeTECH Corp

DemeBOND PB1145019F4P is a Class II device made by DemeTECH Corp, cleared under FDA 510(k) K023030 on 18 Jun 2003 and listed in FDA GUDID since 20 Jun 2019 (UDI-DI 10652927244851), 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) K023030

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 Number10652927244851 UDI-DI Date20 Jun 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK023030 Date18 Jun 2003DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K023030 decided 18 Jun 2003 Active
  • FDA GUDID UDI-DI 10652927244851 listed 20 Jun 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K023030
  2. Listed FDA GUDID 10652927244851

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
DemeBOND
Generic name
Polyester suture, non-bioabsorbable, multifilament, non-antimicrobial
Model / reference
PB1145019F4P
Primary DI / UDI-DI
10652927244851
510(k) Number
FDA product code
GAT
GMDN term
Polyester suture, non-bioabsorbable, multifilament, non-antimicrobial
Device class
Class II
Regulation number
878.5000
GUDID distribution status
In Commercial Distribution

Similar devices in this category

Other devices filed under Polyester suture, non-bioabsorbable, multifilament.

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Properties

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