FDA.reportPublic FDA data

Non-Sterile Probe Storage Covers

Primary DI
80841912104266
Brand
Non-Sterile Probe Storage Covers
Company
PROTEK MEDICAL PRODUCTS, INC.
Model
1160
Published
2020-12-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
KKXDrape, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KKXDrape, SurgicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K970889000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K970889000ULTRASOUND TRANSDUCER DRAPEProtek Medical Products, Inc.1997-10-20KKX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
80841912104266PackageGS14In Commercial Distribution
70841912104269PrimaryGS10
00841912104260Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
8084191210426680841912104266
7084191210426970841912104269
00841912104260008419121042608419121042600841912104260

GMDN Terms#

Term, Definition table
TermDefinition
Body-surface ultrasound imaging transducer coverA device/material intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gels) and/or to maintain the required hygienic level of an ultrasound system imaging transducer (probe) used on the body surface during an ultrasound examination. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
965417181
Device count
100
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841912104717Probe Storage Covers11402021-09-20
00841912100507CT Control Cover100610062016-09-16
00841912100538CT Monitor Cover 100910092016-09-16
00841912100545CT Control Cradle Cover101010102016-09-16
00841912100552System Cover Kit101110112016-09-16
00841912100583Neoprobe Sterile Sleeve Kit with PullUp/pull off extension102710272016-09-16
00841912100590System Drape102810282016-09-16
00841912100606PullUp Instrument Cover103010302016-09-16
00841912100637RTP Universal Stepper/Stabilizer Drape12022016-09-16
00841912100644System Drape Kit121212122016-09-16
00841912100651System Drape Kit121312132016-09-16
00841912100668Isoloader Surgical Drape1214S5521332016-09-16
00841912100675System Drape with Pocket121712172016-09-16
00841912100866Cord Cover Kit194019402016-09-16
00841912104369The Guard Sterile Barrier1205KM12052016-09-16
00841912105021ClingTouch Sterile Disposable Monitor Cover018001802017-09-29
00841912105335Sterile Disposable System Drape Kit128012802017-11-17
00841912105618Terminator XRT Sterile Drape1228TXRT-SD2018-06-06
00841912106035Sterile Sleeve for Gamma Finder III103110312019-06-10
00841912106042System Cover107410742020-11-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08056646500321Oral Surgery SetOMNIA SRLKKX2026-03-27
08056646500482Oral Surgery PackOMNIA SRLKKX2026-03-27
10812564036022MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036077MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036107MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036183MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036190MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036213MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036381MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
20080196017017MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
20888277636726MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
20888277660943MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
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