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Specials SR-0991-16

by SeaSpine Orthopedics Corporation

Specials SR-0991-16 is a Class I device made by SeaSpine Orthopedics Corporation, listed in FDA GUDID since 24 Mar 2023 (UDI-DI 10889981308209), registry data as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10889981308209 UDI-DI Date24 Mar 2023ListedStatusListed 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  • Withdrawn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
Specials
Generic name
Co-oximetry analyser IVD, point-of-care
Model / Ref / Catalog
SR-0991-16
Primary DI / UDI-DI
10889981308209
FDA product code
LXH
GMDN term
Co-oximetry analyser IVD, point-of-care
Device class
Class I
Regulation number
888.4540
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Similar devices

Other devices filed under FDA product code LXH (Orthopedic manual surgical instrument).

Other devices from SeaSpine Orthopedics Corporation

See all devices from SeaSpine Orthopedics Corporation →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (11, all answered No)