FDA.reportPublic FDA data

30977 See Sharp - Enhanced Intraoperative Laparoscope Cleaning & Defogging

Primary DI
00787551037029
Brand
30977 See Sharp - Enhanced Intraoperative Laparoscope Cleaning & Defogging
Company
XODUS MEDICAL, INC.
Model
30977
Catalog number
30977
Device description
30977 See Sharp - Enhanced Intraoperative Laparoscope Cleaning & Defogging
Published
2022-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, general & plastic surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182080000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182080000Scope Antifogging SystemXodus Medical, Inc.2018-09-19GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20787551037023PackageGS116In Commercial Distribution
00787551037029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2078755103702320787551037023
00787551037029007875510370297875510370290787551037029

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope antifog solutionA liquid substance intended to be used to prevent the occurrence of condensed vapour (fog) on the lens of an endoscopic instrument during treatment. It will typically be used on the lens of an endoscopic camera where the warmth from an enclosed body cavity creates the conditions to produce fog on the lens. This device will typically be contained in a spray can, bottle, or squeeze bottle. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(724)337-5500plloyd@xodusmedical.com

Regulatory Flags#

DUNS number
868042664
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00787551041668LPK10037 Lateral Positioning KitLPK10037LPK100372026-10-19
00787551041675LPK10036 Lateral Positioning KitLPK10036LPK100362026-10-19
00787551041682SPK10756 Surgical BackPack KitSPK10756SPK107562026-10-19
00787551041699NSCL24484 Custom Med Label PackNSCL24484NSCL244842026-10-19
00787551041705NSCL25027 Custom Med Label PackNSCL25027NSCL250272026-10-19
0078755104171240675 Hot Pink Pad XL - with Arm Protectors40675406752026-10-19
00787551041637SPK11761 Jackson Table KitSPK11761SPK117612026-07-27
00787551041644SPK11773 Surgical BackPack KitSPK11773SPK117732026-07-27
00787551041651SPK11774 Surgical BackPack KitSPK11774SPK117742026-07-27
0078755100057330500 Cautery Tip Cleaner30500305002017-05-01
0078755101304740670 Hot Pink Pad Controller (Assembled)40670406702026-04-30
0078755104140840671 Hot Pink Pad XL - with Arm Protectors40671406712026-04-30
00787551041415SPK11731 Jackson Table KitSPK11731SPK117312026-04-30
0078755104142240697 The Pink Pad XL - Advanced Trendelenburg Positioning Kit with Adult Head R40697406972026-04-30
00787551041439LPK10035 Lateral Positioning KitLPK10035LPK100352026-04-30
00787551041446CL25313 Custom Med Label PackCL25313CL253132026-04-30
0078755104153840440 Trendelenburg One-Step Arm Protectors Low Profile40440404402026-04-30
0078755104154580566 Camel Mat - Ultra Absorbent Mat (Large) w/ Adhesive80566805662026-04-30
0078755104155280564 Camel Mat - Ultra Absorbent Mat (Extra Large) w/ Adhesive80564805642026-04-30
00787551041569CL25312 Custom Med Label PackCL25312CL253122026-04-30

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