FDA.report

EMERGE MEDICAL & Design

Primary DI
00886020028817
Brand
EMERGE MEDICAL & Design
Company
EMERGE MEDICAL, INC.
Model
329.05.EM
Catalog number
329.05.EM
Device description
BENDING IRON FOR 2.7MM & 3.5MM PLATES
Published
2015-07-08
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

Product Codes

CodeName
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00886020028817PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00886020028817008860200288178860200288170886020028817

GMDN Terms

TermDefinition
Orthopaedic fixation plate bending insert, reusableA device that is inserted into the threaded or non-threaded hole of a metal orthopaedic fixation plate (e.g., trauma or craniofacial plate) prior to the surgeon bending the plate to conform to the anatomical shape of the implant site (e.g., jawbone or pelvis) in order to preserve the integrity of the holes which would otherwise deform, negating the entry of the bone screws that hold the plate in place. It is typically made of metal or synthetic material in the form of a short screw or pin-like device with a slotted head (for the acceptance of a screwdriver) used solely during the bending of plates that typically have a continuous row of screw holes. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
078642955
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
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00886020026424EMERGE MEDICAL & Design319.289.EM319.289.EM2015-07-08
00886020026448EMERGE MEDICAL & Design319.291.EM319.291.EM2015-07-08
00886020026462EMERGE MEDICAL & Design319.25.EM319.25.EM2015-07-08
00886020026493EMERGE MEDICAL & Design319.26.EM319.26.EM2015-07-08
00886020026578EMERGE MEDICAL & Design319.24.EM319.24.EM2015-07-08
00886020028916EMERGE MEDICAL & Design398.95.EM398.95.EM2015-07-08
00886020028923EMERGE MEDICAL & Design399.091.EM399.091.EM2015-07-08
00886020026417EMERGE MEDICAL & Design319.293.EM319.293.EM2015-07-08
00886020026431EMERGE MEDICAL & Design319.292.EM319.292.EM2015-07-08
00886020026455EMERGE MEDICAL & Design319.38.EM319.38.EM2015-07-08
00886020026479EMERGE MEDICAL & Design319.35.EM319.35.EM2015-07-08
00886020026554EMERGE MEDICAL & Design319.46.EM319.46.EM2015-07-08
00886020026899EMERGE MEDICAL & Design309.501.EM309.501.EM2015-07-08
00886020026677EMERGE MEDICAL & Design319.70.EM319.70.EM2015-07-08
00886020026684EMERGE MEDICAL & Design311.689.EM311.689.EM2015-07-08
00886020026998EMERGE MEDICAL & Design319.703.EM319.703.EM2015-07-08
00886020028602EMERGE MEDICAL & Design319.004.EM319.004.EM2015-07-08
00886020028619EMERGE MEDICAL & Design319.006.EM319.006.EM2015-07-08
00886020028657EMERGE MEDICAL & Design323.025.EM323.025.EM2015-07-08
00886020030308EMERGE MEDICAL & Design319.01.EM319.01.EM2015-07-08

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