FDA.reportPublic FDA data

Dinamic OR Gerstner Double Wide Orange Cover Labeled A1-A8

Primary DI
00869653000221
Brand
Dinamic OR Gerstner Double Wide Orange Cover Labeled A1-A8
Company
FLEX OPERATING ROOM, LLC
Model
2000A-B
Catalog number
2000A-B
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Contact Domains#

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
K101598000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101598000EMM SURGICAL DRAPE SMS W/PE SIDES MODEL 13-005 (WITH MINOR DIMENSIONAL VARIATIONS FOR ALTERNATE CONFIGURATIONS)Exact Medical Manufacturing, Inc.2010-10-04KKX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10869653000228PackageGS112In Commercial Distribution
00869653000221PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086965300022810869653000228
00869653000221008696530002218696530002210869653000221

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.

Contacts#

Phone, Email table
PhoneEmail
585-635-7260greg@gerstnermedical.com

Regulatory Flags#

DUNS number
080180725
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975424191761Flex Operating Room, LLC111-21112023-03-30
06975424191778Flex Operating Room, LLC111-32222023-03-30
00869653000245Dinamic OR Gerstner Triple Wide Orange Cover Labeled A1-A123000A-B3000A-B2016-09-20
00869653000238Dinamic OR Gerstner Double Wide Blue Cover Labeled B1-B82000B-B2000B-B2016-09-20
10869653000228Dinamic OR Gerstner Double Wide Orange Cover Labeled A1-A82000A-B2000A-B2016-09-20
10869653000235Dinamic OR Gerstner Double Wide Blue Cover Labeled B1-B82000B-B2000B-B2016-09-20
10869653000242Dinamic OR Gerstner Triple Wide Orange Cover Labeled A1-A123000A-B3000A-B2016-09-20
00869653000207Dinamic OR Spine Rack Monitor Cover 60x64cmGerstner-Moncover-01AGerstner-Moncover-01A2016-09-20
00869653000214Dinamic OR Spine Rack Monitor Cover 60x64cmGerstner-Moncover-01AGerstner-Moncover-01A2016-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975424190771Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.KKX2026-07-16
00628110259448MolecuLightDX Sterile Surgical Sleeve Convenience Kit of 25MolecuLight IncKKX2026-07-08
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
06975085709480Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.KKX2024-07-12
10080196176700Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196496648Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196496655Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
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