FDA.reportPublic FDA data

E6202 Camera Drape, Perf.Tip, Cardb. Insert, 13cmx237cm - 5"x93"

Primary DI
00816953025270
Brand
E6202 Camera Drape, Perf.Tip, Cardb. Insert, 13cmx237cm - 5"x93"
Company
EXACT MEDICAL MANUFACTURING, INC.
Model
E6202
Published
2016-11-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816953025270PackageGS150In Commercial Distribution
00816953025287PackageGS1100In Commercial Distribution
00816953025263PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816953025270008169530252708169530252700816953025270
00816953025287008169530252878169530252870816953025287
00816953025263008169530252638169530252630816953025263

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

Contacts#

Phone, Email table
PhoneEmail
716-681-0866rdean@exactmm.com

Regulatory Flags#

DUNS number
014464314
Device count
1
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16975424198729Proficient SurgicalPS20372026-03-11
16975424198736Proficient SurgicalPS89462026-03-11
26975424198832Exact Medical Manufacturing, Inc.VPS-G4SC-S1VPS-G4SC-S12026-03-09
16975424199276Exact Medical Manufacturing, Inc.E6997E69972026-03-09
26975424198443Exact Medical Manufacturing, Inc.TMPH-2000TMPH-20002025-11-19
26975424198450Exact Medical Manufacturing, Inc.TMPH-2002TMPH-20022025-11-19
26975424198467Exact Medical Manufacturing, Inc.PS-6000PS-60002025-11-19
16975424196206Exact Medical Manufacturing, Inc.E6828E68282026-01-05
16975424198682Exact Medical Manufacturing, Inc.CH1000CH10002026-01-05
16975424198057Exact Medical Manufacturing, Inc.E6380E63802025-12-19
16975424198675Exact Medical Manufacturing, Inc.E6381E63812025-12-19
26975424198269Exact Medical Manufacturing, Inc.E6684E66842025-12-03
26975424198283Exact Medical Manufacturing, Inc.E6685E66852025-12-03
26975424198306Exact Medical Manufacturing, Inc.E6686E66862025-12-03
26975424198320Exact Medical Manufacturing, Inc.E6687E66872025-12-03
26975424198344Exact Medical Manufacturing, Inc.E6688E66882025-12-03
26975424198368Exact Medical Manufacturing, Inc.E6689E66892025-12-03
26975424198382Exact Medical Manufacturing, Inc.E6690E66902025-12-03
26975424198535Exact Medical Manufacturing, Inc.ASP46-80ASP46-802025-11-26
16975424198514Exact Medical Manufacturing, Inc.041130-10A041130-10A2025-11-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16975424198736Proficient SurgicalEXACT MEDICAL MANUFACTURING, INC.KKX2026-03-11
00812564036025MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
00812564036070MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
00812564036100MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
00812564036186MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
00812564036193MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
00812564036216MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
00812564036384MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10080196017010MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10888277636729MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10888277660946MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10888277660953MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10884389185780MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10888277635555MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-10
10888277357037MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-10
26975424198832Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.KKX2026-03-09
16975424199276Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.KKX2026-03-09
10193489036954MedlineMEDLINE INDUSTRIES, INC.KKX2026-02-11
10193489036961MedlineMEDLINE INDUSTRIES, INC.KKX2026-02-11
10193489036978MedlineMEDLINE INDUSTRIES, INC.KKX2026-02-11
10193489036985MedlineMEDLINE INDUSTRIES, INC.KKX2026-02-11
10193489040098MedlineMEDLINE INDUSTRIES, INC.KKX2026-02-11
20885632426299HalyardOWENS & MINOR DISTRIBUTION, INC.KKX2026-01-30
20885632426312HalyardOWENS & MINOR DISTRIBUTION, INC.KKX2026-01-30
20885632426329HalyardOWENS & MINOR DISTRIBUTION, INC.KKX2026-01-30
20885632426336HalyardOWENS & MINOR DISTRIBUTION, INC.KKX2026-01-30
20885632426343HalyardOWENS & MINOR DISTRIBUTION, INC.KKX2026-01-30
20885632426350HalyardOWENS & MINOR DISTRIBUTION, INC.KKX2026-01-30
20885632426367HalyardOWENS & MINOR DISTRIBUTION, INC.KKX2026-01-30
20885632426374HalyardOWENS & MINOR DISTRIBUTION, INC.KKX2026-01-30