FDA.reportPublic FDA data

Scope Guard

Primary DI
00821925008014
Brand
Scope Guard
Company
Gyrus ACMI, LLC
Model
TEL-SH
Device description
Scope Guard Protective Sheath For M3 and G27 Telescopes
Published
2016-10-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K030684000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K030684000SCOPE GUARD PROTECTIVE SHEATH, MODEL TEL-SHAcmi Corporation2003-06-03OCU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821925008014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925008014008219250080148219250080140821925008014

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization/disinfection containerA receptacle designed to hold wrapped and/or unwrapped medical devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots for microsurgical instruments, and stacking capabilities. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
007198742
Device count
1
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
00821925034013Expandacell708907302018-09-13
00821925034020Gyrus ACMI708909072018-09-13
00821925034037Gyrus ACMI708909082018-09-13
00821925034532Gyrus ACMI8909112018-09-13
00821925037069Rhino Rocket708907292018-09-13
00821925037076Rhino Rocket708907312018-09-13
00821925037090Gyrus ACMI708907332018-09-13
00821925037106SlimLine708907342018-09-13
00821925037113Gyrus ACMI708907352018-09-13
00821925037120Gyrus ACMI708907372018-09-13
00821925037137Gyrus ACMI708907382018-09-13
00821925037144Gyrus ACMI708907392018-09-13
00821925037151Gyrus ACMI708907402018-09-13
00821925037168Gyrus ACMI708907412018-09-13
00821925037175Gyrus ACMI708907422018-09-13
00821925037182Gyrus ACMI708907432018-09-13
00821925037199Gyrus ACMI708907502018-09-13
00821925037205Gyrus ACMI708907512018-09-13
00821925037212Gyrus ACMI708907522018-09-13
00821925037229Gyrus ACMI708907532018-09-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060602250321Protech SMEDITECH ENDOSCOPY LTDOCU2026-01-30
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
10816765013417Endo-BootUS EndoscopyOCU2016-09-17
10816765013424Endo-BootUS EndoscopyOCU2016-09-17
20816765013414Endo-BootUS EndoscopyOCU2016-09-17
20816765013421Endo-BootUS EndoscopyOCU2016-09-17