FDA.report

Birkova

Primary DI
00724995205461
Brand
Birkova
Company
STERIS CORPORATION
Model
Table Pads
Catalog number
SB1205
Device description
Heavy Fill 5 LBS. Sand Bag with Grommet, 8 inch x 10 inch
Published
2021-06-30
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
LWGSURGICAL TABLE CUSHION

Product Code Classifications

CodeDeviceSpecialtyClass
LWGSurgical Table CushionGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00724995205461PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995205461007249952054617249952054610724995205461

GMDN Terms

TermDefinition
Traction weightA device in the form of a filled bag intended to be used with a system of rope and pulleys, or a bed traction system, to apply traction forces by means of gravity during medical procedures (e.g., orthopaedic surgery, physical therapy). It is typically filled with sand or steel shot, and may include hangers. This is a reusable device.

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

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