FDA.report

AESCULAP

Primary DI
04038653050147
Brand
AESCULAP
Company
Aesculap AG
Model
LX209R
Catalog number
LX209R
Device description
BOEHLER Traction Bow, diam. 4 mm, depth: 210 mm, width: 160 mm
Published
2017-02-26
Public version status
Update
Distribution status
Not 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
FSMTRAY, SURGICAL, INSTRUMENT

Product Code Classifications

CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04038653050147PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04038653050147040386530501474038653050147

GMDN Terms

TermDefinition
Static powered traction systemAn assembly of devices designed to apply continuous traction forces from a motor through harnesses typically attached to the cervical or lumbar vertebrae. It usually consists of a mains electricity (AC-powered) motor with a control unit to generate and regulate the mechanical forces, and a cord (e.g., braided nylon) clamped to harnesses to transmit the force. Adjustable spreader bars attached to the control unit may be used to vary the angle at which the cord applies traction. The assembly may be table/wall-mounted for horizontal cervical and lumbar traction, or vertical cervical traction. It is used to widen intervertebral spaces to treat prolapsed intervertebral disks and other disorders.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags

DUNS number
315018218
Device count
1
DM exempt
true
Premarket exempt
false
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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