FDA.report

NA

Primary DI
00724995165246
Brand
NA
Company
STERIS CORPORATION
Model
X-Ray Table Top
Catalog number
BF646
Device description
The Bariatric Table radiolucent modular Extenders with four-inch Pads increase the width of the Amsco 4085, 5085, 5085 SRT and Cmax Surgical Tables by 28-inches. The set includes 2 Extenders for the Back and Seat Sections.
Published
2021-04-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FQOTABLE, OPERATING-ROOM, AC-POWERED

Product Code Classifications

CodeDeviceSpecialtyClass
FQOTable, Operating-Room, Ac-PoweredGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00724995165246PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995165246007249951652467249951652460724995165246

GMDN Terms

TermDefinition
Universal operating table topA component of a modular operating table designed as a detachable table top that can be adjusted to support a patient during many types of surgical interventions. It may consists of many articulated sections that can be elevated or lowered for contouring to accommodate numerous anatomical positions (e.g., the whole table top may be adjusted to form a curved surface), or intended to be used in conjunction with dedicated accessories (i.e., positioners, traction devices) to satisfy the requirements of many clinical specialties; it may have x-ray transparent features.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags

DUNS number
036985604
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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00724995153724AmscoWarming CabinetDJ0301441312026-02-13
00724995153731AmscoWarming CabinetDJ04014431112026-02-13
00724995153748AmscoWarming CabinetDJ0401443312026-02-13
00724995153755AmscoWarming CabinetDJ0501441322026-02-13
00724995153762AmscoWarming CabinetDJ0501443322026-02-13
00724995153786AmscoWarming CabinetDJ0601441312026-02-13
00724995153793AmscoWarming CabinetDJ06014431132026-02-13
00724995153809AmscoWarming CabinetDJ0601443312026-02-13
00724995154165AmscoWarming CabinetDJ060144123122026-02-13
00724995158422AmscoWarming CabinetCB46210020012026-02-13
00724995222031NATable ExtensionBF002612026-02-13
00724995222055NATable ExtensionBF002632026-02-13
00724995222062NATable ExtensionBF002642026-02-13
00724995222079NATable ExtensionBF002652026-02-13
00724995222086NATable ExtensionBF002662026-02-13
00724995222093NATable ExtensionBF002672026-02-13
00724995222109NATable ExtensionBF002682026-02-13
00724995244972NATAB800KTLBF7942026-02-13
00724995246891NATable Pad S00XWBF7682026-02-13
00724995246907NATable Pad S20CV3BF7692026-02-13

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