FDA.reportPublic FDA data

Endo Optiks®

Primary DI
30886158016022
Brand
Endo Optiks®
Company
Beaver-Visitec International, Inc.
Model
OME4000
Device description
E4 Endoscopy System
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HQPUnit, cautery, thermal, battery-powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQPUnit, Cautery, Thermal, Battery-PoweredOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K910532000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K910532000URAM OPHTHALMIC LASER ENDOSCOPEMartin S. Knopf Assoc., Inc.1991-05-28HQF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30886158016022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3088615801602230886158016022

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry place.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866)906-8080customersupport@beaver-visitec
+1(866)906-8080customersupport@beaver-visitec.com

Regulatory Flags#

DUNS number
001406024
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00886158152385BVI58531215948652026-10-27
00886158152392BVI58531315948652026-10-27
00886158152408BVI58531015948652026-10-27
00886158152415BVI58531115948652026-10-27
30886158015292Parasol®A14-200A14-2002022-02-01
30886158015315Parasol®A14-2022022-02-01
30886158015322PARASOL®A14-203A14-2032022-02-02
30886158015414Parasol®A14-202BN2022-02-01
30886158015421PARASOL®A14-203BNA14-203BN2022-02-02
30886158015544PARASOL®A14-203QLA14-203QL2022-02-02
30886158012550Ultracell40400-82016-09-19
30886158012604UltracellNS40400-82016-09-19
30886158012611UltracellS40400-82016-09-19
30886158012628Ultracell408102016-09-19
30886158012642Ultracell408002016-09-20
30886158012659Ultracell40405-82016-09-19
30886158013205UltraClean™408152016-09-19
30886158014714UltracellBS40400-82016-09-19
30886158016015Endo Optiks®OME20002016-09-30
30886158002254Visitec®5810195810192024-06-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10840113232908BovieASPEN SURGICAL PRODUCTS, INC.HQP2026-09-21
10840113232922BovieASPEN SURGICAL PRODUCTS, INC.HQP2026-09-21
10840113232946BovieASPEN SURGICAL PRODUCTS, INC.HQP2026-09-21
10840113232960BovieASPEN SURGICAL PRODUCTS, INC.HQP2026-09-21
10840113232984BovieASPEN SURGICAL PRODUCTS, INC.HQP2026-09-21
10840113233004BovieASPEN SURGICAL PRODUCTS, INC.HQP2026-09-21
10840113233028BovieASPEN SURGICAL PRODUCTS, INC.HQP2026-09-21
10840113233042BovieASPEN SURGICAL PRODUCTS, INC.HQP2026-09-21
10840113233066BovieASPEN SURGICAL PRODUCTS, INC.HQP2026-09-21
10840113233080BovieASPEN SURGICAL PRODUCTS, INC.HQP2026-09-21
10840113233165BovieASPEN SURGICAL PRODUCTS, INC.HQP2026-09-21
10840113233189BovieASPEN SURGICAL PRODUCTS, INC.HQP2026-09-21
10840113233264BovieASPEN SURGICAL PRODUCTS, INC.HQP2026-09-21
10840113233547BovieASPEN SURGICAL PRODUCTS, INC.HQP2026-09-21
00886158106586BVIBeaver-Visitec International, Inc.HQP2025-09-10
00886158106593BVIBeaver-Visitec International, Inc.HQP2025-09-10
00886158106609BVIBeaver-Visitec International, Inc.HQP2025-08-11
00886158034247BVIBeaver-Visitec International, Inc.HQP2025-07-22
00886158034674BVIBeaver-Visitec International, Inc.HQP2025-07-22
00886158034681BVIBeaver-Visitec International, Inc.HQP2025-07-22
00886158037569BVIBeaver-Visitec International, Inc.HQP2025-07-22
00886158037576BVIBeaver-Visitec International, Inc.HQP2025-07-22
10887482175160BovieASPEN SURGICAL PRODUCTS, INC.HQP2024-08-28
10887482177119BovieASPEN SURGICAL PRODUCTS, INC.HQP2024-08-28
10887482177133BovieASPEN SURGICAL PRODUCTS, INC.HQP2024-08-28
10887482177157BovieASPEN SURGICAL PRODUCTS, INC.HQP2024-08-28
10887482177171BovieASPEN SURGICAL PRODUCTS, INC.HQP2024-08-28
10887482177201BovieASPEN SURGICAL PRODUCTS, INC.HQP2024-08-28
10887482177225BovieASPEN SURGICAL PRODUCTS, INC.HQP2024-08-28
10887482177249BovieASPEN SURGICAL PRODUCTS, INC.HQP2024-08-28