FDA.reportPublic FDA data

GAMMA

Primary DI
04546540377890
Brand
GAMMA
Company
Stryker Trauma GmbH
Model
1320-3042S
Catalog number
1320-3042S
Device description
Drill, AO small
Published
2020-04-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
04546540377890PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546540377890045465403778904546540377890

GMDN Terms#

Term, Definition table
TermDefinition
Fluted surgical drill bit, single-use, sterileA sterile 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
330211587
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
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
07613327376210T2 ALPHA2351-0390S2351-0390S2023-12-13
07613327361797T2 ALPHA2351-3080S2351-3080S2023-05-25
07613327361803T2 ALPHA2351-3100S2351-3100S2023-05-25
07613327406153T2 ALPHA2351-3082S2351-3082S2023-05-25
07613327406184T2 ALPHA2351-3102S2351-3102S2023-05-25
07613327095548T21806-14201806-14202022-04-27
07613153179443T21896-50551896-50552022-01-31
04546540202475T21896-50351896-50352022-01-27
07613153179368T21896-50251896-50252022-01-27
07613153179375T21896-50301896-50302022-01-27
07613153179399T21896-50401896-50402022-01-27
07613153179412T21896-50451896-50452022-01-27
07613153179436T21896-50501896-50502022-01-27
07613153179467T21896-50601896-50602022-01-27
07613153179474T21896-50651896-50652022-01-27
07613153179481T21896-50701896-50702022-01-27
07613153179498T21896-50751896-50752022-01-27
07613153179504T21896-50801896-50802022-01-27
07613153179511T21896-50851896-50852022-01-27
07613153179528T21896-50901896-50902022-01-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00198506091025ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091032ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091049ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091056ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091063ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091070ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091087ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
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