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Cmf MANAGEL01

by Djo, LLC

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

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

PMA P210016

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00190446922490 UDI-DI Date31 Jul 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPRL from GUDID NumberP210016 Date17 Jan 2025DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

GUDID

Trade name
Cmf
Generic name
Skin topical coupling gel
Model / reference
MANAGEL01
Primary DI / UDI-DI
00190446922490
PMA number
FDA product code
LOF
GMDN term
Skin topical coupling gel
Device class
Class II
Regulation number
890.5870
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (P210016)

Other devices from Djo, LLC

See all devices from Djo, LLC →

Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date

Other properties (11)

  • Supplied sterile: No
  • Sterilise before use: No
  • Single use: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No