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NexPak X 9110534

by Hemostasis, LLC

NexPak X 9110534 is a Class I device made by Hemostasis, LLC, listed in FDA GUDID since 30 Sep 2020 (UDI-DI 00858439001637), 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 Number00858439001637 UDI-DI Date30 Sep 2020ListedStatusListed 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  • Withdrawn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
NexPak X
Generic name
Intranasal splint, non-biodegradable
Model / reference
9110534
Primary DI / UDI-DI
00858439001637
FDA product code
LYA
GMDN term
Intranasal splint, non-biodegradable
Device class
Class I
Regulation number
874.4780
GUDID distribution status
In Commercial Distribution
Size
Length — 2.0 Inch
Width — 0.6 Inch

Similar devices in this category

Other devices filed under Intranasal splint, non-biodegradable.

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Properties

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