FDA.reportPublic FDA data

EMERGE MEDICAL & Design

Primary DI
00886020026882
Brand
EMERGE MEDICAL & Design
Company
EMERGE MEDICAL, INC.
Model
311.59.EM
Catalog number
311.59.EM
Device description
CANNULATED TAP FOR 4.5MM CANNULATED SCREWS
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

Product Codes#

Code, Name table
CodeName
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00886020026882PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00886020026882008860200268828860200268820886020026882

GMDN Terms#

Term, Definition table
TermDefinition
Bone tap, reusableA metal surgical instrument designed for cutting internal threads into bone so that the threads facilitate the insertion of bone screws. The screws anchor bone fragments, fixtures and/or other devices to the bone. It is made of high-grade stainless steel and has a helical thread intersected with longitudinal cutting grooves forming the cutting edges at its distal end and may be cannulated. The proximal end typically terminates in a square to which a tapping instrument or extension can be attached. It will typically be manually rotated in order to create a best possible thread. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
078642955
Device count
1
Premarket exempt
true
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
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00840286860109Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
00840286860116Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
10705034647463N/AMedos International SàrlLXH2026-07-09
B382SD49400B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49401B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49402B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49403B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49404B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49405B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49406B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49407B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49408B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49409B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49410B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49411B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49412B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49413B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49414B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49415B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49416B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49417B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49418B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49419B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49420B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500010Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500020Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500030Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500040Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500050Surgical DirectSurgical Direct, Inc.LXH2026-07-09