FDA.reportPublic FDA data

ZEOS

Primary DI
00812231031193
Brand
ZEOS
Company
SANTA BARBARA IMAGING SYSTEMS, INC.
Model
84-24-4011
Device description
6.5MM HIGH FLOW SHEATH, SINGLE STOPCOCK, 30/70DEG
Published
2024-07-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NBHAccessories, Arthroscopic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBHAccessories, ArthroscopicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812231032657PackageGS11In Commercial Distribution
00812231031193PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812231032657008122310326578122310326570812231032657
00812231031193008122310311938122310311930812231031193

GMDN Terms#

Term, Definition table
TermDefinition
Arthroscopic access cannula, single-useA single-lumen surgical device intended to be percutaneously inserted into a joint to create an access port for an arthroscope/arthroscopic instrument during arthroscopy. The cannula is designed to facilitate the passage of surgical instruments while preventing the escape of irrigation fluid and typically includes an internal watertight seal, and a port for drainage of fluid. It is available in a variety of dimensions and/or designs and may include one or more obturator(s) to facilitate insertion. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
805-770-2110Info@sbimagingsystems.com

Regulatory Flags#

DUNS number
065016344
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812231033906Pixa85-10-64322026-06-08
00812231033913Pixa85-10-64332026-06-08
00812231033920Pixa85-10-65322026-06-08
00812231034095Pixa85-10-64722026-06-08
00812231034101Pixa85-10-64732026-06-08
00812231032886OMNI83-20-500283-20-50022020-09-17
00812231032893OMNI83-20-500383-20-50032020-09-17
00853460007153Imaging (ZEOS)84-20-500484-20-50042018-12-03
00853460007160Imaging (ZEOS)84-20-500584-20-50052018-12-03
00812231030349ZEOS84-20-500284-20-50022018-08-23
00812231030356ZEOS84-20-500384-20-50032018-08-30
00812231034323ZEOS84-10-64322026-01-19
00812231034330ZEOS84-10-64332026-01-19
00812231034347ZEOS84-10-65322026-01-19
00812231034354ZEOS84-10-64722026-01-19
00812231034361ZEOS84-10-64732026-01-19
00812231034859ZEOS84-10-64362026-01-19
00812231034866ZEOS84-10-64372026-01-19
00812231034873ZEOS84-10-64762026-01-19
00812231034880ZEOS84-10-64772026-01-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888867576070Arthrex®ARTHREX, INC.NBH2026-10-20
00888867576087Arthrex®ARTHREX, INC.NBH2026-10-20
00888867568280Arthrex®ARTHREX, INC.NBH2026-10-16
00888867568297Arthrex®ARTHREX, INC.NBH2026-10-16
00888867568303Arthrex®ARTHREX, INC.NBH2026-10-16
00888867568310Arthrex®ARTHREX, INC.NBH2026-10-16
00888867568457Arthrex®ARTHREX, INC.NBH2026-10-16
B382SD4830070Surgical DirectSurgical Direct, Inc.NBH2026-10-15
B382SD4840320Surgical DirectSurgical Direct, Inc.NBH2026-10-15
B382SD18146S90Surgical DirectSurgical Direct, Inc.NBH2026-10-13
B382SD316490Surgical DirectSurgical Direct, Inc.NBH2026-10-13
B382SD316690Surgical DirectSurgical Direct, Inc.NBH2026-10-13
B382SD316890Surgical DirectSurgical Direct, Inc.NBH2026-10-13
B382SD4810320Surgical DirectSurgical Direct, Inc.NBH2026-10-13
B382SD482014PH0Surgical DirectSurgical Direct, Inc.NBH2026-10-13
B382SD482036PH0Surgical DirectSurgical Direct, Inc.NBH2026-10-13
B382SD4843590Surgical DirectSurgical Direct, Inc.NBH2026-10-13
B382SD488200810Surgical DirectSurgical Direct, Inc.NBH2026-10-13
00888867620964Arthrex®ARTHREX, INC.NBH2026-10-12
00888867620971Arthrex®ARTHREX, INC.NBH2026-10-12
00888867620988Arthrex®ARTHREX, INC.NBH2026-10-12
00888867620995Arthrex®ARTHREX, INC.NBH2026-10-12
00190776434021MillenniumAvalign Technologies, Inc.NBH2026-10-09
00190776434106MillenniumAvalign Technologies, Inc.NBH2026-10-09
00190776433680MillenniumAvalign Technologies, Inc.NBH2026-10-07
00190776433123MillenniumAvalign Technologies, Inc.NBH2026-10-01
04055207071786NARichard Wolf GmbHNBH2026-10-01
04055207071830NARichard Wolf GmbHNBH2026-10-01
00190776431495MillenniumAvalign Technologies, Inc.NBH2026-09-22
00190776432119MillenniumAvalign Technologies, Inc.NBH2026-09-22