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
00821925033900DIEGO701390022024-07-25
00821925033917DIEGO701390062024-07-24
00821925034419DIEGO701390332024-07-23
00821925034730Gyrus ACMI703531002017-05-11
00821925034754Gyrus ACMI703531122017-05-11
00821925035935OLYMPUS37402016-10-03
00821925001428GYRUS ACMICW-USLPC2016-10-13
00821925035874OLYMPUS30002016-09-30
00821925035911Gyrus ACMI34002016-10-12
00821925041547Gyrus ACMI30252016-09-30
00821925010567Gyrus ACMI39992024-07-24
00821925002746Gyrus ACMIENDO-ST2016-10-14
00821925011410DIEGO703390012016-10-12
00821925011441DIEGO703380002017-05-11
00821925021594SMART701421682015-10-24
00821925021617VOCOM701430192015-10-24
00821925026179Diego703380122016-10-06
00821925028746Diego703390002016-10-06
00821925034174Gyrus ACMI701410322015-10-24
00821925035898OLYMPUS30062016-09-30

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