FDA.reportPublic FDA data

PullUp Instrument Cover

Primary DI
00841912100491
Brand
PullUp Instrument Cover
Company
PROTEK MEDICAL PRODUCTS, INC.
Model
1003
Catalog number
1003
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
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
10841912100498PackageGS124In Commercial Distribution
00841912100491PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084191210049810841912100498
00841912100491008419121004918419121004910841912100491

GMDN Terms#

Term, Definition table
TermDefinition
Instrument/equipment drape, single-use, sterileA sterile device made of natural and/or synthetic flexible materials intended to be used as a non-dedicated protective covering for various surgical and/or non-surgical instruments/equipment [e.g., surgical tray, operating room (OR) equipment table, endoscope and endoscopic instruments, surgical cameras and lasers], to provide a barrier against cross-contamination in various clinical settings. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
965417181
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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
08056646500291Basic Implant SetOMNIA SRLKKX2026-03-27
08056646500307Implantology SetOMNIA SRLKKX2026-03-27
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
20888277660950MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
40884389185781MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
20888277635552MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-10
40888277357038MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-10
10080196176700Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
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10080196496686Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497164Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497171Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497188Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497195Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497720Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497744Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196498239Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196498376Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29