FDA.report

NA

Primary DI
00724995165284
Brand
NA
Company
STERIS CORPORATION
Model
X-Ray Table Top
Catalog number
BF664
Device description
The Bariatric Table Extenders without Pads: Leg Section are radiolucent modular Extenders that increases the width of the Cmax, 4085, 5085 and or 5085SRT Surgical Tables by 28-inches. The set includes two Extenders each for the Leg Section.
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
10724995165281PrimaryGS10
00724995165284Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1072499516528110724995165281
00724995165284007249951652847249951652840724995165284

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
2
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

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00724995153762AmscoWarming CabinetDJ0501443322026-02-13
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00724995153809AmscoWarming CabinetDJ0601443312026-02-13
00724995154165AmscoWarming CabinetDJ060144123122026-02-13
00724995158422AmscoWarming CabinetCB46210020012026-02-13
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00724995222055NATable ExtensionBF002632026-02-13
00724995222062NATable ExtensionBF002642026-02-13
00724995222079NATable ExtensionBF002652026-02-13

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