FDA.report

AMD-RITMED

Primary DI
20686864052597
Brand
AMD-RITMED
Company
AMD Medicom Inc
Model
A9005
Catalog number
A9005
Device description
AMD-RITMED SURGEON CAP One Size
Published
2019-01-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FYFCAP, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
FYFCap, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20686864052597PackageGS13In Commercial Distribution
10686864052590PrimaryGS10
00686864052593Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2068686405259720686864052597
1068686405259010686864052590
00686864052593006868640525936868640525930686864052593

GMDN Terms

TermDefinition
Surgical cap, single-useA head covering designed as a cap intended to be worn by surgical staff during an operation to protect both the patient and themselves from the transfer of microorganisms, body fluids, and particulate material; it may also be used as a hygienic head covering in other healthcare settings. It is usually made of reinforced paper or non-woven materials. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Cool dry place

Sterilization Methods

Method

Contacts

PhoneEmail
+1(514)636-6262amdudi@medicom.ca

Regulatory Flags

DUNS number
256880576
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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