FDA.reportPublic FDA data

Stratum Ankle

Primary DI
00810082893038
Brand
Stratum Ankle
Company
Medartis Inc.
Model
SA27DRLS
Device description
Stratum Ankle 2.7mm Drill sterile
Published
2023-06-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
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
00810082893038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810082893038008100828930388100828930380810082893038

GMDN Terms#

Term, Definition table
TermDefinition
Fluted surgical drill bit, single-useA shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is mounted into a surgical power tool or a surgical hand drill/brace. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
192756786
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810082898194Calcshift Instrument System1031-100022024-11-27
00810082898200Calcshift Instrument System1031-100042024-11-27
00810082898217Calcshift Instrument System1031-110052024-11-27
00810082898231Calcshift Instrument System1031-110062024-11-27
00810082898255Calcshift Instrument System1031-100072024-11-27
00810082898262Calcshift Instrument System1031-10008-12024-11-27
00810082898279Calcshift Instrument System1031-10008-22024-11-27
00810082898286Calcshift Instrument System1031-10008-32024-11-27
00810082898293Calcshift Instrument System1031-10008-42024-11-27
00810082898309Calcshift Instrument System1031-10008-52024-11-27
00810082898316Calcshift Instrument System1031-100092024-11-27
00810082898323Calcshift Instrument System1031-100102024-11-27
00810082898330Calcshift Instrument System1031-100112024-11-27
00810082898354Calcshift Instrument System1031-110132024-11-27
00810082898378Calcshift Instrument System1031-100142024-11-27
00810082898385Calcshift Instrument System1031-100152024-11-27
00810082898392Calcshift Instrument System1031-100162024-11-27
00810082898521Calcshift Instrument System1031-100172024-11-27
00810082898538Calcshift Instrument System1031-100182024-11-27
00817701029472Calcshift Instrument System1034-100012024-11-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00198506091070ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091087ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
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