FDA.report

NA

Primary DI
03596010466969
Brand
NA
Company
Smith & Nephew, Inc.
Model
013227
Catalog number
013227
Device description
CLAMP TABLE
Published
2015-08-30
Public version status
Update
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
FWZAccessories, operating-room, table (kit)

Product Code Classifications

CodeDeviceSpecialtyClass
FWZOperating Room Accessories Table TrayGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03596010466969PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03596010466969035960104669693596010466969

GMDN Terms

TermDefinition
Medical table clampA device that is designed to be used together with operating tables and certain kinds of examination/treatment tables. It can have different fixation/locking mechanisms, but is often designed to fit onto the side rails of such tables. It is used to hold different components and accessories onto the table providing added functionality. Such devices can be footrests, transducer holders, anaesthesia screen holders. The clamp allows for easy and safe adjustments of the position of these accessory devices and provides a secure locking mechanism. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)821-5700gudid@smith-nephew.com
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags

DUNS number
109903521
Device count
1
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
false
Sterilization required before use
true

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