FDA.report

E6503 Thermo Cover 61x104cm

Primary DI
00816953029339
Brand
E6503 Thermo Cover 61x104cm
Company
EXACT MEDICAL MANUFACTURING, INC.
Model
E6503
Published
2016-11-27
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

Related Records

Contact Domains

Product Codes

CodeName
KKXDrape, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
KKXDrape, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00816953029339PackageGS1100In Commercial Distribution
00816953029346PackageGS1100In Commercial Distribution
00816953029322PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00816953029339008169530293398169530293390816953029339
00816953029346008169530293468169530293460816953029346
00816953029322008169530293228169530293220816953029322

GMDN Terms

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

Contacts

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

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Primary DIBrandCompanyProduct codePublished
16975424198736Proficient SurgicalEXACT MEDICAL MANUFACTURING, INC.KKX2026-03-11
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10888277660953MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
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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
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