FDA.report

C-Core 19104 Split Drape 60" X 70" (6" X 21" Split)-

Primary DI
00817602020240
Brand
C-Core 19104 Split Drape 60" X 70" (6" X 21" Split)-
Company
EXACT MEDICAL MANUFACTURING, INC.
Model
19104
Catalog number
19104
Published
2016-09-27
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

Product Codes

CodeName
KKXDrape, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
KKXDrape, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817602020240PackageGS196In Commercial Distribution
00817602020233PrimaryGS10

GMDN Terms

TermDefinition
Patient surgical drape, single-use, sterileA sterile, noninvasive flat sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to isolate a specific anatomical site (e.g., site of surgical incision) from potential contamination (e.g., microbial, substance). The device may also be used to protect a patient from heat/flame during a surgical procedure, however it is not designed with specific heat-reflective or laser resistant materials. 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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