FDA.report

Starr Frame

Primary DI
00618125174652
Brand
Starr Frame
Company
TIDI PRODUCTS, LLC
Model
29745
Device description
Carbon Fiber - Accessories Various Various 1in x 1in x 1in 1 per Each
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
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
KXJTable, radiologic

Product Code Classifications

CodeDeviceSpecialtyClass
KXJTable, RadiologicRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00618125174652PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00618125174652006181251746526181251746520618125174652

GMDN Terms

TermDefinition
Instrument tableA table used for laying out sterile surgical instruments, sutures, and other utensils/items required during an operation or intervention. It is designed to include an appropriate, e.g., stainless steel, top or surface with no crevices, screws or rivets, and most tables include telescoping pedestals for height adjustment and swivel caster bases. This table is used in the so-called "sterile area" of the operation site and in some cases may be attached to the operating table.

Sterilization Methods

Method

Regulatory Flags

DUNS number
063519193
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
true
Sterilization required before use
false

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