FDA.reportPublic FDA data

Endo-Boot

Primary DI
20724995184012
Brand
Endo-Boot
Company
US Endoscopy
Model
00711621
Catalog number
00711621
Device description
The Endo-Boot tip protector is used as a protective cover for the tip of the endoscope or other surgical instruments during storage and transport.
Published
2020-04-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

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
K951104000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K951104000ENDOBOOTUnited States Endoscopy Group, Inc.1995-04-06OCU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20724995184012PackageGS12In Commercial Distribution
10816765013417PreviousGS10
10724995184015PrimaryGS10
00724995184018Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2072499518401220724995184012
1081676501341710816765013417
1072499518401510724995184015
00724995184018007249951840187249951840180724995184018

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument guard, single-use, sterileA sterile device designed to be applied to a variety of surgical or invasive instruments to protect the instrument and/or its operator and/or the patient from injury, distortion, or damage during a procedure, handling, and/or storage. It is typically made of stainless steel or plastic materials. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
627879687
Device count
25
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995182557Exacto00711094007110942021-03-31
00724995182564Exacto00711095007110952021-03-31
00724995182618Exacto00711115007111152021-03-31
00724995243746Exacto Mundo00711114007111142025-01-31
00724995180959VIA00717001007170012020-01-31
00724995181116VIA00717019007170192020-01-30
00724995181420VIA00717051007170512020-01-30
00724995181451VIA00717054007170542020-01-30
00724995181505VIA00717059007170592020-01-30
00724995181659VIA00717076007170762020-01-30
00724995182984VIA00717141007171412020-01-30
00724995183073VIA00717155007171552020-07-16
00724995183141VIA00717167007171672020-01-30
00724995183257VIA00717182007171822020-01-30
00724995190699VIA00717223007172232020-01-30
00724995190736VIA00717234007172342020-01-30
00724995193966VIA00717269007172692020-02-04
00724995194123VIA00717229007172292020-02-07
00724995194987VIA00717310007173102020-03-23
00724995203412VIA00717337007173372020-10-20

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
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