FDA.reportPublic FDA data

EMERGE MEDICAL & Design

Primary DI
00886020029586
Brand
EMERGE MEDICAL & Design
Company
EMERGE MEDICAL, INC.
Model
242.31.EM
Catalog number
242.31.EM
Device description
2.7MM L-PLATE 3 HOLES /32MM-RIGHT
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
Single use
true

Product Codes#

Code, Name table
CodeName
HRSPLATE, FIXATION, BONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00886020029586PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00886020029586008860200295868860200295860886020029586

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, non-bioabsorbable, non-sterileA non-sterile implantable sheet of firm material intended to be attached to fractured long bone fragments with screws to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to treat traumatic or pathological orthopaedic fractures; it may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion). This device is intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
078642955
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00886020008109EMERGE MEDICAL & Design211.841.EM211.841.EM2015-07-07
00886020008116EMERGE MEDICAL & Design211.842.EM211.842.EM2015-07-07
00886020008123EMERGE MEDICAL & Design211.843.EM211.843.EM2015-07-07
00886020008130EMERGE MEDICAL & Design211.844.EM211.844.EM2015-07-07
00886020008147EMERGE MEDICAL & Design211.845.EM211.845.EM2015-07-07
00886020008154EMERGE MEDICAL & Design211.846.EM211.846.EM2015-07-07
00886020008161EMERGE MEDICAL & Design211.847.EM211.847.EM2015-07-07
00886020008178EMERGE MEDICAL & Design211.848.EM211.848.EM2015-07-07
00886020008185EMERGE MEDICAL & Design211.849.EM211.849.EM2015-07-07
00886020008284EMERGE MEDICAL & Design211.810.EM211.810.EM2015-07-07
00886020008291EMERGE MEDICAL & Design211.811.EM211.811.EM2015-07-07
00886020008307EMERGE MEDICAL & Design211.812.EM211.812.EM2015-07-07
00886020008314EMERGE MEDICAL & Design211.813.EM211.813.EM2015-07-07
00886020008321EMERGE MEDICAL & Design211.814.EM211.814.EM2015-07-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613154605453MATTAStryker GmbHHRS2025-09-16
07613154320288MATTAStryker GmbHHRS2023-10-20
07613154320332MATTAStryker GmbHHRS2023-10-20
07613154320349MATTAStryker GmbHHRS2023-10-20
07613154320356MATTAStryker GmbHHRS2023-10-20
07613154320363MATTAStryker GmbHHRS2023-10-20
07613154320370MATTAStryker GmbHHRS2023-10-20
07613154320387MATTAStryker GmbHHRS2023-10-20
07613154320394MATTAStryker GmbHHRS2023-10-20
07613154320400MATTAStryker GmbHHRS2023-10-20
07613154320417MATTAStryker GmbHHRS2023-10-20
07613154320455MATTAStryker GmbHHRS2023-10-20
07613154320479MATTAStryker GmbHHRS2023-10-20
07613154320516MATTAStryker GmbHHRS2023-10-20
07613154320530MATTAStryker GmbHHRS2023-10-20
07613154320547MATTAStryker GmbHHRS2023-10-20
07613154320608MATTAStryker GmbHHRS2023-10-20
07613154320622MATTAStryker GmbHHRS2023-10-20
07613154320653MATTAStryker GmbHHRS2023-10-20
07613154320677MATTAStryker GmbHHRS2023-10-20
07613154320707MATTAStryker GmbHHRS2023-10-20
07613154320714MATTAStryker GmbHHRS2023-10-20
07613154320721MATTAStryker GmbHHRS2023-10-20
07613154320752MATTAStryker GmbHHRS2023-10-20
07613154320783MATTAStryker GmbHHRS2023-10-20
07613154320790MATTAStryker GmbHHRS2023-10-20
07613154320806MATTAStryker GmbHHRS2023-10-20
07613154320813MATTAStryker GmbHHRS2023-10-20
07613154320882MATTAStryker GmbHHRS2023-10-20
07613154320943MATTAStryker GmbHHRS2023-10-20