FDA.report

EMERGE MEDICAL & Design

Primary DI
00886020031084
Brand
EMERGE MEDICAL & Design
Company
EMERGE MEDICAL, INC.
Model
73C.EM
Catalog number
73C.EM
Device description
7.3MM CANNULATED SCREW CADDY ASSEMBLY
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
OJHOrthopedic tray

Product Code Classifications

CodeDeviceSpecialtyClass
OJHOrthopedic TrayGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00886020031084PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00886020031084008860200310848860200310840886020031084

GMDN Terms

TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. 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
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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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