FDA.reportPublic FDA data

Protech S

Primary DI
05060602250321
Brand
Protech S
Company
MEDITECH ENDOSCOPY LTD
Model
INOV8-028S
Device description
ENDOSCOPIC STORAGE COVER
Published
2026-01-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
OCUEndoscopic Storage Cover

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCUEndoscopic Storage CoverGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191011000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191011000Scope ProTechMeditech Endoscopy, Ltd.2019-05-07OCU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060602250321PrimaryGS10
05060602250307Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060602250321050606022503215060602250321
05060602250307050606022503075060602250307

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope sheath, single-useA component of a rigid or flexible endoscope assembly designed as a tube through which an endoscope (e.g., hysteroscope) and endoscopic elements are introduced and assembled to create a complete operative endoscopic unit; it is also designed to function as a protective barrier to isolate the endoscope from patient contact and prevent contamination of the endoscope controls during a procedure. It typically contains ports to enable the insertion of instruments (through the endoscope or through independent working channels), insufflation ports, valves and connectors. It is made of plastic and metal materials. This is a single-use device.

Regulatory Flags#

DUNS number
219397009
Device count
100
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060602250567Protech XLINOV8-0442026-01-30
05060602250307Protech SINOV8-028S2026-01-30
05060602250543Protech XLINOV8-0442026-01-30
05060602250314Protech LINOV8-028L2026-01-28
05060602250291Protech LINOV8-028L2026-01-28
15060602250021ECO EZ CLEANSEINOV8-0022023-08-25
05060602250024ECO EZ CLEANSEINOV8-0022023-08-25
15060602250014VALVESAFEINOV8-0012023-08-24
05060602250017VALVESAFEINOV8-0012023-08-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060602250567Protech XLMEDITECH ENDOSCOPY LTDOCU2026-01-30
05060602250307Protech SMEDITECH ENDOSCOPY LTDOCU2026-01-30
05060602250543Protech XLMEDITECH ENDOSCOPY LTDOCU2026-01-30
05060602250314Protech LMEDITECH ENDOSCOPY LTDOCU2026-01-28
05060602250291Protech LMEDITECH ENDOSCOPY LTDOCU2026-01-28
04897106952892andorate® Universal Endoscope Tip GuardGA Health Company LimitedOCU2022-01-28
04897106953547andorate® Universal Endoscope Tip GuardGA Health Company LimitedOCU2022-01-28
14897106952899andorate® Universal Endoscope Tip GuardGA Health Company LimitedOCU2022-01-28
14897106953544andorate® Universal Endoscope Tip GuardGA Health Company LimitedOCU2022-01-28
00724995190637ProArmorUS EndoscopyOCU2020-07-16
00724995190644ProArmorUS EndoscopyOCU2020-07-16
10724995190634ProArmorUS EndoscopyOCU2020-07-16
10724995190641ProArmorUS EndoscopyOCU2020-07-16
10724995184015Endo-BootUS EndoscopyOCU2020-04-01
10724995184022Endo-BootUS EndoscopyOCU2020-04-01
20724995184012Endo-BootUS EndoscopyOCU2020-04-01
20724995184029Endo-BootUS EndoscopyOCU2020-04-01
00821925008014Scope GuardGyrus ACMI, LLCOCU2016-10-18
10816765013417Endo-BootUS EndoscopyOCU2016-09-17
10816765013424Endo-BootUS EndoscopyOCU2016-09-17
20816765013414Endo-BootUS EndoscopyOCU2016-09-17
20816765013421Endo-BootUS EndoscopyOCU2016-09-17