FDA.report

NA

Primary DI
04546540152503
Brand
NA
Company
STRYKER CORPORATION
Model
0400204000
Catalog number
0400204000
Device description
Wall Rack (Holds 4 Helmets)
Published
2018-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
LYUACCESSORY, SURGICAL APPAREL

Product Code Classifications

CodeDeviceSpecialtyClass
LYUAccessory, Surgical ApparelGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04546540152503PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04546540152503045465401525034546540152503

GMDN Terms

TermDefinition
Wall mountA non-dedicated (general-purpose) manually-operated device designed to be permanently fixed to a wall and from which another medical device(s) is intended to be safely suspended, affixed, or mounted. [This group of devices does not include wall mounts that are dedicated to a device(s)].

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)253-3210Inst.Stryker.cs@Stryker.com

Regulatory Flags

DUNS number
196548481
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
false
Sterilization required before use
false

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